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

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.