Provant Therapy of Venous Stasis Ulcer Trial

Southern California Institute for Research and Education2 sites in 1 country25 target enrollmentNovember 2009

ConditionsVenous Stasis Ulcers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Venous Stasis Ulcers
Sponsor: Southern California Institute for Research and Education
Enrollment: 25
Locations: 2
Primary Endpoint: Rates of wound closure (measured as change in surface area - mm2/day)
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot study hypothesizes that use of the Regenesis Provant Wound Therapy System (a radiofrequency device) twice daily over venous stasis ulcers (wounds thought to occur due to improper functioning of valves in the veins, usually of the legs) will result in increased rates of healing and a larger proportion of completely healed wounds after 12 weeks of therapy compared to wounds treated identically using a Provant device that is not activated to emit radiofrequency.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

November 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Southern California Institute for Research and Education

Eligibility Criteria

Inclusion Criteria

•Ulcer size between 1.0 and 16.0 cm2 at the time of randomization - measurements to be taken after sharp debridement if this is performed at the screening visit. Wounds must be free of necrotic tissue and fibrin slough after debridement with at least 90% of the surface covered with granulation tissue.
•Target ulcer must be present for at least 6 weeks prior to randomization. Other ulcers close to the study ulcer are allowable and may be any size but should be greater than 2cm away from the study ulcer; no more than 4 ulcers total on the target limb are allowed.
•A duplex ultrasound study documenting venous disease must be performed within on year of study entry. The ultrasound exam should document either chronic occlusion of the target limb popliteal, femoral, or iliac veins or the vena cava, or occlusion in the greater or lesser saphenous veins, or reflux in either the deep, saphenous, or perforating veins.

Exclusion Criteria

•No ulcer on the target limb including the study ulcer may be deep enough to expose structures deep to the adipose lay of skin such as muscle, fascia, tendon, joint, or bone. The presence of sinus tracts that have not been sufficiently marsupialized such that the wound depth can be assessed by gross visual inspection is similarly exclusion.
•At the Screening or Randomization Visits, the presence of significant periwound cellulitis or the need to administer systemic antibiotics. system antibiotic therapy for any indication within 10 days of screening is an exclusion.
•Baseline arterial studies obtained within one year of screening or at the screening visit must show either an ankle-brachial index of the affected limb greater or equal to 0.75 based on the higher of the two pedal arteries systolic pressure measured with Doppler ultrasound compared to the ipsilateral brachial artery systolic pressure determined with Doppler ultrasound.
•Any major surgery or trauma affecting the target limb such as tibial fracture, knee arthroplasty, endovascular or open arterial or venous surgery or femoral stenting within 180 days of randomization.
•Participation in any clinical trial involving therapy for wound healing within 30 days of randomization.
•Concurrent administration of systemic agents that influence wound healing such as prednisone or dexamethasone in any quantity, cytotoxic chemotherapy agents, or immunosuppressive therapy.
•Previous ionizing radiation therapy at any dose near the wound bed (within 5 cm).
•A history of cancer in the target limb except for previous skin cancer treated in the target limb provided that a biopsy of the target wound is obtained within 90 days of randomization that confirms the absence of neoplasia.
•Severe renal failure - serum creatinine greater than 2.5 or subject on hemodialysis.
•Severe hepatic insufficiency: known cirrhosis, any degree of ascites, serum transamines more than three times the upper limit of normal.