A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers

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

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.

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.

Inclusion Criteria:

1. Males and females > 18 years of age
2. History of Type 1 or 2 Diabetes Mellitus
3. A diabetic plantar foot wound, Wagner grade 1 or 2 (See Exclusion Criteria, number four (4).
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.
5. Ankle Brachial Index (ABI) score ≥ 0.7 and ≤ 1.2 with present palpable posterior tibial pulse or dorsalis pedis pulse in index foot
6. Wound surface area ≥ 1.0 cm2 and ≤ 16.0 cm2
7. 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:

1. Glycosylated Hemoglobin (HbA1c) greater than 12 within 30 days of enrollment
2. Absent pedal Doppler signals in the foot with the index wound or the presence of significant peripheral artery disease ,
3. 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.
4. Index wounds with exposed muscle, ligament or tendon, or which probe to bone regardless of classification-See Inclusion Criteria no. two ( 2).
5. Wounds due to a nondiabetic etiology (e.g. venous stasis, arterial insufficiency, etc.)
6. Cellulitis, osteomyelitis, or other clinical evidence of infection involving the index wound.
7. History of malignancy
8. Concurrent use of high dose immunosuppressant or cytotoxic drugs
9. Implanted pacemaker or defibrillator
10. Metallic implant involving the index foot or ankle
11. Implanted system with a metallic lead
12. Pregnant or lactating females
13. Concurrent participation in another clinical trial. 14) An unwillingness of the patient to comply with the study procedures and the required follow-up regimen.