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Provant Therapy of Venous Stasis Ulcer Trial

NCT01050023 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2011-07-20

No results posted yet for this study

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.

Conditions

  • Venous Stasis Ulcers

Interventions

DEVICE

Provant Device (Wound Therapy System)

Twice daily application of the active Provant device to the wound for twelve (12) weeks.

DEVICE

Provant Device - Inactive

Twice daily application of the inactive Provant device to the wound for twelve (12) weeks.

Sponsors & Collaborators

  • Regenesis Biomedical, Inc.

    collaborator INDUSTRY

  • Southern California Institute for Research and Education

    lead OTHER

Principal Investigators

  • Ian Gordon, M.D., Ph.D. · VA Long Beach Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01050023 on ClinicalTrials.gov