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Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)

Primary Purpose

Osteomyelitis, Diabetes, Amputation

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rifampin
Riboflavin Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteomyelitis focused on measuring Rifampin, Double-blind, Clinical Trial, Veterans, Diabetes

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 and 89 years
  2. Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days > 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years
  3. Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment.
  4. All planned debridement has been completed prior to randomization.
  5. A course of backbone antimicrobial therapy has been selected.

Exclusion Criteria:

  1. Patient unable to receive enteral medication.
  2. Patient is allergic to or intolerant of rifampin.
  3. Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk.
  4. Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer.
  5. Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C.
  6. Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained.
  7. Patient has an ALT > 3 times the upper limit of normal for the site laboratory, or total bilirubin > 2.5 times the upper limit of normal for the site laboratory*,***; INR > 1.5, OR patient has Child-Pugh Class C Cirrhosis.
  8. Patient has a baseline white blood cell count (WBC) <2000 cells/mm3*** OR absolute neutrophil count (ANC) <1000 cells/mm3*** OR platelet count <50,000 cells/mm3**,*** OR hemoglobin <8.0 g/dL.**,***.
  9. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test.
  10. Patient is believed unlikely to be able to complete the trial due to medical conditions.
  11. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses.
  12. Patient refuses or is clinically unable to undergo the recommended level of debridement.
  13. Indwelling hardware present in the foot, at the site of the index osteomyelitis.
  14. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days.
  15. Patient is receiving therapy for COVID-19 that interacts with rifampin.

    • Patients with total bilirubin > 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study.

      • Patients with platelet count <50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study.

        • If multiple laboratory values are available, the most recent value will be applied for eligibility.

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZ
  • VA Loma Linda Healthcare System, Loma Linda, CARecruiting
  • VA Long Beach Healthcare System, Long Beach, CARecruiting
  • VA Palo Alto Health Care System, Palo Alto, CARecruiting
  • VA Northern California Health Care System, Mather, CARecruiting
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Rocky Mountain Regional VA Medical Center, Aurora, CORecruiting
  • Washington DC VA Medical Center, Washington, DCRecruiting
  • Bay Pines VA Healthcare System, Pay Pines, FLRecruiting
  • North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
  • Miami VA Healthcare System, Miami, FL
  • James A. Haley Veterans' Hospital, Tampa, FLRecruiting
  • Atlanta VA Medical and Rehab Center, Decatur, GA
  • VA Ann Arbor Healthcare System, Ann Arbor, MIRecruiting
  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting
  • St. Louis VA Medical Center John Cochran Division, St. Louis, MO
  • James J. Peters VA Medical Center, Bronx, NYRecruiting
  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NCRecruiting
  • Cincinnati VA Medical Center, Cincinnati, OHRecruiting
  • Louis Stokes VA Medical Center, Cleveland, OHRecruiting
  • Dayton VA Medical Center, Dayton, OHRecruiting
  • Oklahoma City VA Medical Center, Oklahoma City, OKRecruiting
  • VA Portland Health Care System, Portland, ORRecruiting
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TNRecruiting
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXRecruiting
  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
  • South Texas Health Care System, San Antonio, TXRecruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting
  • Salem VA Medical Center, Salem, VARecruiting
  • William S. Middleton Memorial Veterans Hospital, Madison, WIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active drug

Placebo

Arm Description

Patients receive oral adjunctive rifampin therapy

Patients receive oral riboflavin

Outcomes

Primary Outcome Measures

Amputation-Free Survival
The primary endpoint is amputation-free survival, ending with amputation or death from any cause. Amputation is defined as surgical treatment of osteomyelitis by removal or debridement of necrotic/infected bone (all or part of a bone) from a lower extremity limb or digit on the ipsilateral side of the protocol-treated osteomyelitis. Debridement prior to randomization may include removal of bone. Because this debridement occurs early, prior to exposure to study drug or placebo, removal of bone at that time is not a study endpoint.

Secondary Outcome Measures

Time to Amputation
Time from randomization to the occurrence of the components of the primary outcome: the first occurrence of ipsilateral amputation alone the first occurrence of ipsilateral above-ankle amputation the first occurrence of ipsilateral through the ankle (e.g. Symes amputation) or below-ankle amputation proximal to the metatarsal-phalangeal joint the first occurrence of ipsilateral below-ankle amputation at or distal to the metatarsal-phalangeal joint all cause death Endpoint will be determined by chart review by the Study Coordinator, with confirmation by the Site Investigator, and as needed, by the Study Chair.
New course of antibacterial therapy for ipsilateral foot infection
New courses of antibacterial therapy for ipsilateral foot infection during the first year after randomization (yes/no per patient). Endpoint will be determined by chart review by the Study Coordinator, with consultation with the Site Investigator as needed to confirm that the new course of treatment is directed toward continued or recurrent osteomyelitis of the initially affected lower extremity. The new course will require there be at least a 14 day interval between the end of the initial back-bone antibiotic therapy course.
Quality of Life - SF-36
Quality of life, measured by the 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992) and its physical and mental health subscales. This is a widely used self-report instrument that will be administered by the Study Coordinator at baseline, 3-, 6- and 12-months.
Ambulatory Status
Ambulatory status, measured by the Study Coordinator, using a modified item from the Amputee Mobility Predictor Questionnaire56. The patient's "usual method of ambulation within the home" will be assessed by a single self-report item at baseline, 3-, 6- and 12-months using the following response categories: No assistive device required to move about Cane Crutches Walker Wheelchair Bed bound
Incidence of Falls
Incidence of falls, measured by self-reported frequency of falls and falls that required medical attention in the one-month periods preceding research visits at Baseline, 3-, 6- and 12-months.
Incidence of adverse events related to direct toxicity of rifampin
Incidence of adverse events related to direct toxicity of rifampin in active drug vs. placebo groups: Nausea requiring dividing the dose to twice a day Rash requiring study drug discontinuation Nausea requiring study drug discontinuation Grade 3 or 4 liver enzyme (ALT) elevations Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.
Incidence of adverse events from drug interactions
Incidence of adverse events from drug interactions in active drug vs. placebo groups: Cardiovascular: Myocardial infarction, cerebrovascular accident, hospitalization for hypertensive emergency Glycemic control: Hospitalization for a primary diagnosis of hypoglycemia or uncontrolled diabetes Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.
Comparative dropout
Overall comparative dropout data during the 6-week intervention based on drug intolerance/drug interactions/adverse events in active drug vs. placebo groups. Dropout endpoint will be determined by chart review by the Study Coordinator and by telephone calls to the subject.
Remission of osteomyelitis
Remission of osteomyelitis at 12 months (yes/no). Remission is defined as epithelialization of any overlying soft tissue defect and the absence of local signs and symptoms of inflammation. Endpoint will be determined by physical examination by the Site Investigator at the 12 month visit.
Complete epithelialization of the wound
Complete epithelialization of the wound at 6 weeks and at 3, 6 and 12 months (yes/no). Endpoint will be determined by physical examination by the Site Investigator at the 3, 6 and 12 month visits.
First occurrence of ipsilateral amputation related to index osteomyelitis
Time from randomization to the first occurrence of ipsilateral amputation for the treatment of osteomyelitis related to the index osteomyelitis. Relatedness will be determined by the LSI or qualified Co-investigator on thePrimary Outcome case report form. An episode of ipsilateral osteomyelitis is considered related to the index osteomyelitis if it involves the same bone or a contiguous bone.

Full Information

First Posted
December 22, 2016
Last Updated
August 21, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03012529
Brief Title
Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
Acronym
VA INTREPID
Official Title
CSP #2001 - Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA Intrepid)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
January 22, 2024 (Anticipated)
Study Completion Date
January 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in diabetic patients. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis in both diabetics and non-diabetics. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many Veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
Detailed Description
This is a prospective, randomized, double-blind, placebo-controlled, investigation of a six week course of adjunctive rifampin vs. adjunctive matched placebo (riboflavin) added to backbone antibacterial therapy for the treatment of diabetic foot osteomyelitis. Backbone antibacterial therapy will be with single or multiple agents selected by the clinical treatment team based either on culture results or standard empiric therapy, and which can be administered either intravenously or orally. Rifampin will be dosed at 600 mg daily. The primary outcome measure is amputation-free survival. Amputation events include both below- and above-ankle amputations. Primary outcomes will be determined by systematic medical record review and through confirmatory research visits, phone calls and, as needed, information from non-VA providers. The results for amputation-free survival will be analyzed by means of a two-sided log-rank test. The secondary outcomes of complete wound epithelialization and remission of osteomyelitis will be determined by the research team through VA record review and/or direct examination. The study will initially enroll and randomize a total of 880 study participants to receive either rifampin or placebo (riboflavin) in addition to backbone antibiotic therapy prescribed by their clinician. Investigators expect to enroll, on average, close to one subject per month per site (10-12 per year/site) at 28 VA medical centers to achieve total randomization of 880 subjects over three years. In meeting this average site enrollment projection, Investigators anticipate variation in enrollment between larger and smaller sites, and between high-performing and low-performing sites. Subjects will be followed through the end of the second year after randomization or until a study primary endpoint event (amputation or death) occurs. On average, study participants will be followed for 1.8 years through systematic review of medical records, and by study visits and phone calls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomyelitis, Diabetes, Amputation
Keywords
Rifampin, Double-blind, Clinical Trial, Veterans, Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active drug
Arm Type
Active Comparator
Arm Description
Patients receive oral adjunctive rifampin therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients receive oral riboflavin
Intervention Type
Drug
Intervention Name(s)
Rifampin
Intervention Description
Subjects who are randomly assigned to adjunctive rifampin will receive a 600 mg oral daily dose targeted for a six-week period. If a subject experiences gastrointestinal intolerance on once daily dosing, the study drug may be administered as rifampin 300 mg twice a day.
Intervention Type
Drug
Intervention Name(s)
Riboflavin Placebo
Intervention Description
A placebo capsule will be administered daily to match frequency and duration of rifampin interventional drug. For the purpose of mimicking urine discoloration when taking rifampin, riboflavin will be added to the placebo to produce a urine discoloration effect.
Primary Outcome Measure Information:
Title
Amputation-Free Survival
Description
The primary endpoint is amputation-free survival, ending with amputation or death from any cause. Amputation is defined as surgical treatment of osteomyelitis by removal or debridement of necrotic/infected bone (all or part of a bone) from a lower extremity limb or digit on the ipsilateral side of the protocol-treated osteomyelitis. Debridement prior to randomization may include removal of bone. Because this debridement occurs early, prior to exposure to study drug or placebo, removal of bone at that time is not a study endpoint.
Time Frame
Assessed 2 years post intervention
Secondary Outcome Measure Information:
Title
Time to Amputation
Description
Time from randomization to the occurrence of the components of the primary outcome: the first occurrence of ipsilateral amputation alone the first occurrence of ipsilateral above-ankle amputation the first occurrence of ipsilateral through the ankle (e.g. Symes amputation) or below-ankle amputation proximal to the metatarsal-phalangeal joint the first occurrence of ipsilateral below-ankle amputation at or distal to the metatarsal-phalangeal joint all cause death Endpoint will be determined by chart review by the Study Coordinator, with confirmation by the Site Investigator, and as needed, by the Study Chair.
Time Frame
Assessed 2 years post intervention
Title
New course of antibacterial therapy for ipsilateral foot infection
Description
New courses of antibacterial therapy for ipsilateral foot infection during the first year after randomization (yes/no per patient). Endpoint will be determined by chart review by the Study Coordinator, with consultation with the Site Investigator as needed to confirm that the new course of treatment is directed toward continued or recurrent osteomyelitis of the initially affected lower extremity. The new course will require there be at least a 14 day interval between the end of the initial back-bone antibiotic therapy course.
Time Frame
Assessed 2 years post intervention
Title
Quality of Life - SF-36
Description
Quality of life, measured by the 36-Item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992) and its physical and mental health subscales. This is a widely used self-report instrument that will be administered by the Study Coordinator at baseline, 3-, 6- and 12-months.
Time Frame
Assessed 12 months post intervention
Title
Ambulatory Status
Description
Ambulatory status, measured by the Study Coordinator, using a modified item from the Amputee Mobility Predictor Questionnaire56. The patient's "usual method of ambulation within the home" will be assessed by a single self-report item at baseline, 3-, 6- and 12-months using the following response categories: No assistive device required to move about Cane Crutches Walker Wheelchair Bed bound
Time Frame
Assessed 12 months post intervention
Title
Incidence of Falls
Description
Incidence of falls, measured by self-reported frequency of falls and falls that required medical attention in the one-month periods preceding research visits at Baseline, 3-, 6- and 12-months.
Time Frame
Assessed 12 months post intervention
Title
Incidence of adverse events related to direct toxicity of rifampin
Description
Incidence of adverse events related to direct toxicity of rifampin in active drug vs. placebo groups: Nausea requiring dividing the dose to twice a day Rash requiring study drug discontinuation Nausea requiring study drug discontinuation Grade 3 or 4 liver enzyme (ALT) elevations Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.
Time Frame
Assessed 3 months post intervention
Title
Incidence of adverse events from drug interactions
Description
Incidence of adverse events from drug interactions in active drug vs. placebo groups: Cardiovascular: Myocardial infarction, cerebrovascular accident, hospitalization for hypertensive emergency Glycemic control: Hospitalization for a primary diagnosis of hypoglycemia or uncontrolled diabetes Local Site Investigators, with assistance from their Study Coordinators, will be responsible for reporting adverse events which will be used to analyze these secondary endpoints.
Time Frame
Assessed 3 months post intervention
Title
Comparative dropout
Description
Overall comparative dropout data during the 6-week intervention based on drug intolerance/drug interactions/adverse events in active drug vs. placebo groups. Dropout endpoint will be determined by chart review by the Study Coordinator and by telephone calls to the subject.
Time Frame
Assessed 6 weeks post intervention
Title
Remission of osteomyelitis
Description
Remission of osteomyelitis at 12 months (yes/no). Remission is defined as epithelialization of any overlying soft tissue defect and the absence of local signs and symptoms of inflammation. Endpoint will be determined by physical examination by the Site Investigator at the 12 month visit.
Time Frame
Assessed at 1 year post intervention
Title
Complete epithelialization of the wound
Description
Complete epithelialization of the wound at 6 weeks and at 3, 6 and 12 months (yes/no). Endpoint will be determined by physical examination by the Site Investigator at the 3, 6 and 12 month visits.
Time Frame
Assessed 1 year post intervention
Title
First occurrence of ipsilateral amputation related to index osteomyelitis
Description
Time from randomization to the first occurrence of ipsilateral amputation for the treatment of osteomyelitis related to the index osteomyelitis. Relatedness will be determined by the LSI or qualified Co-investigator on thePrimary Outcome case report form. An episode of ipsilateral osteomyelitis is considered related to the index osteomyelitis if it involves the same bone or a contiguous bone.
Time Frame
Assessed 2 years post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 and 89 years Diagnosis of diabetes mellitus, either by: 1) use of oral hypoglycemic agents or insulin at the time of enrollment; 2) a hemoglobin A1c (HgA1c) level within the past 90 days > 6.5; or 3) a medical record diagnosis of diabetes mellitus by a clinician on two or more occasions in the previous 10 years Definite or probable osteomyelitis in the diabetic foot, as defined by the International Working Group on the Diabetic Foot (Table 1). Criteria must be present at some point within 90 days prior to enrollment. All planned debridement has been completed prior to randomization. A course of backbone antimicrobial therapy has been selected. Exclusion Criteria: Patient unable to receive enteral medication. Patient is allergic to or intolerant of rifampin. Patient is taking a drug that has interactions with rifampin that would require either stoppage, substitution or an empiric dose modification that may place the patient at medical risk. Within 30 days of enrollment, patient is taking immunosuppressive medications to prevent rejection of an organ transplant or is receiving chemotherapy for cancer or molecularly targeted therapies for cancer. Patient is receiving antiretroviral therapy for HIV or antiviral medication for Hepatitis C. Patient is participating in another interventional clinical trial for which a waiver of dual enrollment with CSP#2001 has not been obtained. Patient has an ALT > 3 times the upper limit of normal for the site laboratory, or total bilirubin > 2.5 times the upper limit of normal for the site laboratory*,***; INR > 1.5, OR patient has Child-Pugh Class C Cirrhosis. Patient has a baseline white blood cell count (WBC) <2000 cells/mm3*** OR absolute neutrophil count (ANC) <1000 cells/mm3*** OR platelet count <50,000 cells/mm3**,*** OR hemoglobin <8.0 g/dL.**,***. Women of child-bearing potential (those with menses within the last year) with a positive serum pregnancy test. Patient is believed unlikely to be able to complete the trial due to medical conditions. Patient is believed unlikely to complete the trial due to neurologic and psycho-behavioral disorders such as active substance abuse or dependence, disabling dementias or psychoses. Patient refuses or is clinically unable to undergo the recommended level of debridement. Indwelling hardware present in the foot, at the site of the index osteomyelitis. Treatment with antibacterial agents for infection at another site, where the duration of treatment is anticipated to be greater than 14 days. Patient is receiving therapy for COVID-19 that interacts with rifampin. Patients with total bilirubin > 2 times the ULN who have Gilbert's Disease or any other inherited disease affecting bilirubin metabolism without meeting other exclusionary criteria, may be considered for inclusion in the study. Patients with platelet count <50,000 cells/mm3 due only to hypersplenism and meeting no other exclusionary criteria may be considered for inclusion in the study. If multiple laboratory values are available, the most recent value will be applied for eligibility.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul A Monach, MD PhD
Phone
(857) 364-6662
Email
Paul.Monach@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla R Morrison
Phone
(617) 435-6375
Email
Kayla.Morrison@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary T Bessesen, MD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Terminated
Facility Name
VA Loma Linda Healthcare System, Loma Linda, CA
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Fernando, MD
Phone
909-583-6361
Email
ronald.fernando@va.gov
First Name & Middle Initial & Last Name & Degree
Agnes Lee, LVN
Email
Agnes.Lee2@va.gov
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Gordon, MD
Phone
562-826-8000
Ext
24409
Email
ian.gordon@va.gov
First Name & Middle Initial & Last Name & Degree
Christine Ma, MPH
Email
christine.ma@va.gov
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Holodniy, MD
Phone
650-852-3408
Email
mark.holodniy@va.gov
First Name & Middle Initial & Last Name & Degree
Leonor Lopez, RN
Email
Leonor.Lopez@va.gov
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hien Nguyen, MD
Phone
916-843-9242
Email
hien.nguyen6@va.gov
First Name & Middle Initial & Last Name & Degree
Lam Nguyen, BA
Email
Lam.Nguyen3@va.gov
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Terminated
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Nicholson, MD
Phone
720-723-6772
First Name & Middle Initial & Last Name & Degree
Anna Wyrwa, BSN
Phone
(720) 857-5117
Email
Anna.Wyrwa@va.gov
First Name & Middle Initial & Last Name & Degree
Mary T Bessesen, MD
Facility Name
Washington DC VA Medical Center, Washington, DC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelike Liappis, MD
Phone
202-745-8000
Ext
58301
Email
angelike.liappis@va.gov
First Name & Middle Initial & Last Name & Degree
Shirley Cummins, CCRC
Email
shirley.cummins@va.gov
Facility Name
Bay Pines VA Healthcare System, Pay Pines, FL
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Abercrombie, DPM
Phone
727-398-6661
Ext
17379
Email
Melissa.Abercrombie@va.gov
First Name & Middle Initial & Last Name & Degree
Cortny Withee, BS
Email
Cortny.Withee@va.gov
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Wang, MD
Phone
352-548-6483
Email
Gary.Wang@va.gov
First Name & Middle Initial & Last Name & Degree
Leslie Brown, BA
Email
leslie.brown1@va.gov
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
James A. Haley Veterans' Hospital, Tampa, FL
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Toney, MD
Phone
813-972-2000
Ext
6697
Email
John.Toney@va.gov
First Name & Middle Initial & Last Name & Degree
Natalie Veling, BSN
Email
Natalie.Veling@va.gov
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Terminated
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Linder, MD
Phone
734-222-7598
Email
Kathleen.Linder2@va.gov
First Name & Middle Initial & Last Name & Degree
Kimberly Nofz, BSN
Email
Kimberly.Nofz@va.gov
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derrick Green, MD
Phone
612-467-7275
Email
derrick.green@va.gov
First Name & Middle Initial & Last Name & Degree
Aigerim Toleuova, MN
Email
aigerim.toleuova@va.gov
Facility Name
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Individual Site Status
Terminated
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Gelman, MD
Phone
718-584-9000
Ext
6680
Email
michael.gelman@va.gov
First Name & Middle Initial & Last Name & Degree
Kathleen Escoto, MPH
Email
Kathleen.Escoto@va.gov
Facility Name
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Barroso, MD
Phone
704-638-9000
Ext
13570
Email
Luis.Barroso@va.gov
First Name & Middle Initial & Last Name & Degree
Ashly Hinson, LPN
Email
Ashly.Hinson@va.gov
Facility Name
Cincinnati VA Medical Center, Cincinnati, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Smulian, MD
Phone
513-348-6804
Email
george.smulian@va.gov
First Name & Middle Initial & Last Name & Degree
Laura Lach, BS
Email
Laura.Lach@va.gov
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usha Stiefel, MD
Phone
216-791-3800
Ext
64788
Email
Usha.Stiefel@va.gov
First Name & Middle Initial & Last Name & Degree
Karly Tarase, BSN
Email
Karly.Tarase@va.gov
Facility Name
Dayton VA Medical Center, Dayton, OH
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hari Polenakovik, MD
Phone
937-268-6511
Ext
2630
Email
hari.polenakovik@va.gov
First Name & Middle Initial & Last Name & Degree
Barbara Lane, MSN
Email
Barbara.Lane@va.gov
Facility Name
Oklahoma City VA Medical Center, Oklahoma City, OK
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Kurdgelashvili, MD
Phone
405-456-2544
Email
George.Kurdgelashvili@va.gov
First Name & Middle Initial & Last Name & Degree
Seerat Moutassam, MPH
Email
Seerat.Moutassam@va.gov
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marissa Maier, MD
Phone
503-220-8262
Ext
52363
Email
Marissa.Maier@va.gov
First Name & Middle Initial & Last Name & Degree
Erik Mauk, BS
Email
Erik.Mauk@va.gov
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Hulgan, MD
Phone
615-835-5082
Email
Todd.Hulgan@va.gov
First Name & Middle Initial & Last Name & Degree
Rachel Turgeon, MS
Email
Rachel.Turgeon@va.gov
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Truong, DPM
Phone
214-857-0039
Email
David.Truong1@va.gov
First Name & Middle Initial & Last Name & Degree
Sarah Balogun, BS
Email
Sarah.Balogun@va.gov
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Barshes, MD
Phone
713-791-1414
Ext
25188
Email
neal.barshes@va.gov
First Name & Middle Initial & Last Name & Degree
Alexander Uribe-Gomez, MD
Email
Alexander.Uribe-Gomez@va.gov
Facility Name
South Texas Health Care System, San Antonio, TX
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Cadena Zuluaga, MD
Phone
210-617-5300
Ext
14793
Email
jose.cadena-zuluaga@va.gov
First Name & Middle Initial & Last Name & Degree
Michele Paprocki, MSN
Email
Michele.Paprocki@va.gov
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clint Larsen, DPM
Phone
801-582-1565
Ext
4826
Email
clint.larsen@va.gov
First Name & Middle Initial & Last Name & Degree
Cicilia Velarde, BS
Email
Cicilia.Velarde@va.gov
Facility Name
Salem VA Medical Center, Salem, VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153-6404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shikha Vasudeva, MD
Phone
540-982-2463
Ext
3843
Email
shikha.vasudeva@va.gov
First Name & Middle Initial & Last Name & Degree
Brooke Fuhrey, BS
Email
Brooke.Fuhrey@va.gov
Facility Name
William S. Middleton Memorial Veterans Hospital, Madison, WI
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Crnich, MD
Phone
608-843-0438
Email
christopher.crnich@va.gov
First Name & Middle Initial & Last Name & Degree
Kenneth Wagman, BSN
Email
Kenneth.Wagman@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31914940
Citation
Bessesen MT, Doros G, Henrie AM, Harrington KM, Hermos JA, Bonomo RA, Ferguson RE, Huang GD, Brown ST. A multicenter randomized placebo controlled trial of rifampin to reduce pedal amputations for osteomyelitis in veterans with diabetes (VA INTREPID). BMC Infect Dis. 2020 Jan 8;20(1):23. doi: 10.1186/s12879-019-4751-3.
Results Reference
derived

Learn more about this trial

Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics

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