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

NCT00761176 | Terminated Results

• 1 other identifier: RGI-08-08-1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcers

Keywords

Diabetes; Ulcers; Wounds

Outcome Measures

Primary Outcomes (1)

• The Incidence of Wounds Reaching Complete Closure

  approximate one year

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care will be utilized without the device.

The Provant Therapy System

OTHER

Thirty minutes, twice daily treatment

Device: The Provant Therapy System

Interventions

The Provant Therapy System DEVICE

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

Also known as: Radio frequency generator devices

The Provant Therapy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females \> 18 years of age
• History of Type 1 or 2 Diabetes Mellitus

You may not qualify if:

• 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.
• 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.
• 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

Sponsors & Collaborators

• Regenesis Biomedical, Inc.: lead

Study Sites (1)

Winston - Salem Outpatient Clinic

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: VP of Clinical Research and Regulatory
• Organization: Regenesis Biomedical, Inc.

mark.davis@regenesisbio.com

602-309-2118

Study Officials

• Mike Wilson, DPM

  Winston - Salem Outpatient Clinic, WG Hefner VAMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 5, 2016
• Results First Posted: January 5, 2016

Record last verified: 2015-11

Locations

US (1)