Back to resultsA Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
Primary Purpose
Diabetic Foot Ulcers
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Provant Therapy System
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers focused on measuring Diabetes, Ulcers, Wounds
Eligibility Criteria
Inclusion Criteria:
- Males and females > 18 years of age
- History of Type 1 or 2 Diabetes Mellitus
- A diabetic plantar foot wound, Wagner grade 1 or 2 (See Exclusion Criteria, number four (4).
- The qualifying wound must have been present for ≥ 30 days; (the age of the wound will be recorded) based on patient history or documentation in the medical record.
- Ankle Brachial Index (ABI) score ≥ 0.7 and ≤ 1.2 with present palpable posterior tibial pulse or dorsalis pedis pulse in index foot
- Wound surface area ≥ 1.0 cm2 and ≤ 16.0 cm2
- Female subjects of childbearing age will be expected to test negative after taking a serum pregnancy test. Additionally, they must be willing to use an adequate and reliable method of contraception for the study duration. Females who are postmenopausal must have been postmenopausal at least one year or twelve months.
Exclusion Criteria:
- Glycosylated Hemoglobin (HbA1c) greater than 12 within 30 days of enrollment
- Absent pedal Doppler signals in the foot with the index wound or the presence of significant peripheral artery disease ,
- Concurrent treatment of the index wound with another advanced wound care device (i.e. negative pressure wound therapy, non-contact ultrasound, hyperbaric oxygen, electrical stimulation) or pharmaceutical (e.g. growth factors) within thirty (30) days of enrollment.
- Index wounds with exposed muscle, ligament or tendon, or which probe to bone regardless of classification-See Inclusion Criteria no. two ( 2).
- Wounds due to a nondiabetic etiology (e.g. venous stasis, arterial insufficiency, etc.)
- Cellulitis, osteomyelitis, or other clinical evidence of infection involving the index wound.
- History of malignancy
- Concurrent use of high dose immunosuppressant or cytotoxic drugs
- Implanted pacemaker or defibrillator
- Metallic implant involving the index foot or ankle
- Implanted system with a metallic lead
- Pregnant or lactating females
- Concurrent participation in another clinical trial. 14) An unwillingness of the patient to comply with the study procedures and the required follow-up regimen.
Sites / Locations
- Winston - Salem Outpatient Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Standard of Care
The Provant Therapy System
Arm Description
Standard of Care will be utilized without the device.
Thirty minutes, twice daily treatment
Outcomes
Primary Outcome Measures
The Incidence of Wounds Reaching Complete Closure
Secondary Outcome Measures
Full Information
NCT ID
NCT00761176
First Posted
September 25, 2008
Last Updated
November 30, 2015
Sponsor
Regenesis Biomedical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00761176
Brief Title
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
Official Title
A Controlled Study Comparing Basic Wound Care to the Provant® Therapy System as an Adjunct to Basic Wound Care for Wound Surface Area Reduction in Diabetic Plantar Foot Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Protocol Violations noted for 6 of 8 patients
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regenesis Biomedical, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.
Detailed Description
According to the American Diabetes Association (ADA), there are approximately 20.8 million people in the US with diabetes or 7% of the population (1). A significant number of the diabetic population is prone to pedal ulceration and estimates reveal that 15-20% of this population will develop a foot ulcer in their lifetime.
Treatment of diabetic foot ulcerations have posed a problem to healthcare providers for many years. The literature describes many different modalities for direct wound treatment strategies. Most of these treatments rely on the timely application of biological dressings, offloading of the wound, regular (and often inconvenient) visits to the doctor, and most important, compliance by the patient. It is not uncommon for such wounds to be present for greater than six months, despite use of debridement, off-loading and other basic wound care techniques, before presenting for advanced therapy.
Provant has been selected for study because:
It is already indicated for the adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.
It is a non-invasive wound treatment system which utilizes a proprietary PRFE signal which is hypothesized to trigger the release of endogenous growth factors that induce mitosis through accelerating the cell cycle, using a Ca+2 mediated pathway. The result is a significant increase in the rate of cell replication.
It has also been shown that PRFE triggers a genetic sequence or cascade of 'wound repair' genes critical for the four stages of wound healing: inflammation, granulation, epithelialization, and remodeling.
It has been utilized in the VA Health System since 2004 with no serious adverse events attributable to the device.
This study will assess as an endpoints:
Primary - the incidence of wounds reaching complete closure, and
Secondary - the time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
Keywords
Diabetes, Ulcers, Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of Care will be utilized without the device.
Arm Title
The Provant Therapy System
Arm Type
Other
Arm Description
Thirty minutes, twice daily treatment
Intervention Type
Device
Intervention Name(s)
The Provant Therapy System
Other Intervention Name(s)
Radio frequency generator devices
Intervention Description
The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
Primary Outcome Measure Information:
Title
The Incidence of Wounds Reaching Complete Closure
Time Frame
approximate one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females > 18 years of age
History of Type 1 or 2 Diabetes Mellitus
A diabetic plantar foot wound, Wagner grade 1 or 2 (See Exclusion Criteria, number four (4).
The qualifying wound must have been present for ≥ 30 days; (the age of the wound will be recorded) based on patient history or documentation in the medical record.
Ankle Brachial Index (ABI) score ≥ 0.7 and ≤ 1.2 with present palpable posterior tibial pulse or dorsalis pedis pulse in index foot
Wound surface area ≥ 1.0 cm2 and ≤ 16.0 cm2
Female subjects of childbearing age will be expected to test negative after taking a serum pregnancy test. Additionally, they must be willing to use an adequate and reliable method of contraception for the study duration. Females who are postmenopausal must have been postmenopausal at least one year or twelve months.
Exclusion Criteria:
Glycosylated Hemoglobin (HbA1c) greater than 12 within 30 days of enrollment
Absent pedal Doppler signals in the foot with the index wound or the presence of significant peripheral artery disease ,
Concurrent treatment of the index wound with another advanced wound care device (i.e. negative pressure wound therapy, non-contact ultrasound, hyperbaric oxygen, electrical stimulation) or pharmaceutical (e.g. growth factors) within thirty (30) days of enrollment.
Index wounds with exposed muscle, ligament or tendon, or which probe to bone regardless of classification-See Inclusion Criteria no. two ( 2).
Wounds due to a nondiabetic etiology (e.g. venous stasis, arterial insufficiency, etc.)
Cellulitis, osteomyelitis, or other clinical evidence of infection involving the index wound.
History of malignancy
Concurrent use of high dose immunosuppressant or cytotoxic drugs
Implanted pacemaker or defibrillator
Metallic implant involving the index foot or ankle
Implanted system with a metallic lead
Pregnant or lactating females
Concurrent participation in another clinical trial. 14) An unwillingness of the patient to comply with the study procedures and the required follow-up regimen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Wilson, DPM
Organizational Affiliation
Winston - Salem Outpatient Clinic, WG Hefner VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winston - Salem Outpatient Clinic
City
Winston - Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
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