A Pilot Diabetic Foot Ulcer Study - Full Text View

Sponsored by:	Regenesis Biomedical, Inc.
Information provided by:	Regenesis Biomedical, Inc.
ClinicalTrials.gov Identifier:	NCT00761176

Purpose

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	Intervention
Diabetic Foot Ulcers	Device: The Provant Wound Therapy System

MedlinePlus related topics: Diabetic Foot Foot Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Single Center Controlled Feasibility Study Comparing Standardized Basic Wound Care to the Provant® Wound Therapy System as an Adjunct to Standardized Basic Wound Care With a Primary Focus on Wound Surface Area Reduction in Diabetic Plantar Foot Wounds

Further study details as provided by Regenesis Biomedical, Inc.:

Primary Outcome Measures:

The incidence of wounds reaching complete closure [ Time Frame: approximate one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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. [ Time Frame: approximate one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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 Criteria:

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.)
Cellulitus, 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761176

Contacts

Contact: Rick Isenberg, MD	4809704970	isenberg@regenesisbiomedical.com
Contact: Regina Ponder, JD	4809704970	ponder@regenesisbiomedical.com

Locations

United States, North Carolina
Winston - Salem Outpatient Clinic	Recruiting
Winston - Salem, North Carolina, United States, 27103
Contact: Mike Wilson 336-768-3296 ext 1496 michael.wilson9@med.va.gov
Principal Investigator: Mike Wilson, DPM

Sponsors and Collaborators

Regenesis Biomedical, Inc.

Investigators

Principal Investigator:

Mike Wilson, DPM

Winston - Salem Outpatient Clinic, WG Hefner VAMC

More Information

Responsible Party:	Regenesis Biomedical, Inc. ( Regina Ponder, Director of Clinical Research )
Study ID Numbers:	RGI-08-08-1
Study First Received:	September 25, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00761176
Health Authority:	United States: Institutional Review Board

Keywords provided by Regenesis Biomedical, Inc.:

The study will focus on recalcitrant diabetic foot ulcers that have been present for greater than thirty days.

Study placed in the following topic categories:

Foot Ulcer
Skin Diseases
Diabetic Neuropathies
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Foot Diseases
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009