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

Stopped early · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT00761176

Run by

Regenesis Biomedical, Inc.

People needed

8

Starts

2008-07-01

Expected to finish

2011-03-01

Last updated by the study team

2016-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.)
• Cellulitis, 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.

Where it is running

• Winston - Salem Outpatient Clinic — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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