Status:
TERMINATED
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
Lead Sponsor:
Regenesis Biomedical, Inc.
Conditions:
Diabetic Foot Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00761176
Start Date
July 1 2008
End Date
March 1 2011
Last Update
January 5 2016
Active Locations (1)
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1
Winston - Salem Outpatient Clinic
Winston-Salem, North Carolina, United States, 27103