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Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
doxycycline
placebo gel
Sponsored by
NanoSHIFT LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic, Ulcer, Wound

Eligibility Criteria

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

Inclusion Criteria:

  • Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association

  • Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:

    • Agree to use a double-barrier method of contraception during their participation in this study;

    • condoms (with spermicide) and hormonal contraceptives OR
    • condoms (with spermicide) and intrauterine device OR
    • intrauterine device and hormonal contraceptives OR
    • Abstains from sexual intercourse during their participation in this study OR
    • Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
  • Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
  • Be able to apply study drug to their ulcer, or have a caregiver do it
  • Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
  • Target ulcer is Grade I according to the Wagner Grading Scale
  • Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers
  • Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers

Exclusion Criteria:

  • Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
  • Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
  • Have more than three chronic ulcers present at baseline
  • Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
  • Have connective tissue disease
  • Currently be going through kidney dialysis for renal failure
  • Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days
  • Have participated in another clinical research trial within the last 30 days
  • Have a known history of osteomyelitis affecting to the area where the target ulcer is present
  • Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
  • Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)

Sites / Locations

  • North Florida / South Georgia Veterans Administration Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NanoDOX™ Hydrogel

Placebo

Arm Description

1.0% doxycycline gel

placebo gel

Outcomes

Primary Outcome Measures

Number of Participants Without Adverse Events
Participants were monitored for 20 weeks during the study.

Secondary Outcome Measures

Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)

Full Information

First Posted
October 1, 2008
Last Updated
March 9, 2017
Sponsor
NanoSHIFT LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00764361
Brief Title
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
Official Title
A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of NanoDOX™ Hydrogel(1.0% Doxycycline Monohydrate)in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanoSHIFT LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.
Detailed Description
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic, Ulcer, Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NanoDOX™ Hydrogel
Arm Type
Experimental
Arm Description
1.0% doxycycline gel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo gel
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
1.0% doxycycline gel applied topically to the wound once daily for 20 weeks
Intervention Type
Drug
Intervention Name(s)
placebo gel
Other Intervention Name(s)
doxycycline
Intervention Description
placebo gel applied topically to the wound once daily for 20 weeks
Primary Outcome Measure Information:
Title
Number of Participants Without Adverse Events
Description
Participants were monitored for 20 weeks during the study.
Time Frame
every 2 weeks
Secondary Outcome Measure Information:
Title
Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)
Time Frame
baseline, week 4, week 10, week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and: • Agree to use a double-barrier method of contraception during their participation in this study; condoms (with spermicide) and hormonal contraceptives OR condoms (with spermicide) and intrauterine device OR intrauterine device and hormonal contraceptives OR Abstains from sexual intercourse during their participation in this study OR Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening Be able to apply study drug to their ulcer, or have a caregiver do it Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg Target ulcer is Grade I according to the Wagner Grading Scale Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers Exclusion Criteria: Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control. Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative Have more than three chronic ulcers present at baseline Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months Have connective tissue disease Currently be going through kidney dialysis for renal failure Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days Have participated in another clinical research trial within the last 30 days Have a known history of osteomyelitis affecting to the area where the target ulcer is present Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study. Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Abernethy, MD
Organizational Affiliation
Ology Bioservices
Official's Role
Study Director
Facility Information:
Facility Name
North Florida / South Georgia Veterans Administration Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers

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