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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761176
Recruitment Status : Terminated (Protocol Violations noted for 6 of 8 patients)
First Posted : September 29, 2008
Results First Posted : January 5, 2016
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Regenesis Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: The Provant Therapy System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard of Care
Standard of Care will be utilized without the device.
The Provant Therapy System
Thirty minutes, twice daily treatment
Device: The Provant Therapy System
The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
Other Name: Radio frequency generator devices

Primary Outcome Measures :
  1. The Incidence of Wounds Reaching Complete Closure [ Time Frame: approximate one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761176

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United States, North Carolina
Winston - Salem Outpatient Clinic
Winston - Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Regenesis Biomedical, Inc.
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Principal Investigator: Mike Wilson, DPM Winston - Salem Outpatient Clinic, WG Hefner VAMC
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Responsible Party: Regenesis Biomedical, Inc. Identifier: NCT00761176    
Other Study ID Numbers: RGI-08-08-1
First Posted: September 29, 2008    Key Record Dates
Results First Posted: January 5, 2016
Last Update Posted: January 5, 2016
Last Verified: November 2015
Keywords provided by Regenesis Biomedical, Inc.:
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases