Diabetic Foot Ulcers
Conditions
Keywords
Diabetes, Ulcers, Wounds
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.
Interventions
DEVICEThe Provant Therapy System
The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
Sponsors
Regenesis Biomedical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Incidence of Wounds Reaching Complete Closure | approximate one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active The Provant Wound Therapy System: The Provant Wound Therapy System is a safe adjuvant non-invasive medical device. | 4 |
| Standard of Care Standardized wound care is used | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Active | Standard of Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 4 participants | 4 participants | 8 participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
Outcome results
Primary
The Incidence of Wounds Reaching Complete Closure
Time frame: approximate one year
Population: Analysis was not done as this study was early terminated due to all subjects not meeting inclusion/exclusion criteria.