Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

Revalesio

Status and phase

Completed

Phase 1

Conditions

Venous Stasis Ulcers

Treatments

Device: Revera Wound Care

Device: Normal Saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00823446

RC 03.1.1.HS1

Details and patient eligibility

About

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

Full description

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

This evaluation will be done through tabulations of adverse events (AE), review of complete blood counts (CBC) with differential and platelet, and measuring wound healing rate.

The secondary purpose of the study is a preliminary evaluation of an increase in the healing rate of venous leg ulcers treated with Revera Wound Care.

This evaluation will be done through measuring wound healing rate (which is also being used to evaluate safety) and complete wound healing.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older.
Diagnosis of non-healing venous leg ulcer by the following criteria:
- dependent peripheral edema, dermatitis, hyperpigmentation.
- an ankle to arm arterial pressure ratio > 0.7 as measured by arterial Doppler.
Venous Stasis Ulcer is ≥ 2 cm² in size.
If female subject of reproductive age, have had a negative pregnancy test within one week of study entry and are using adequate birth control.

Exclusion criteria

Subject known to be allergic to Aquacel dressing or components.
Peripheral arterial insufficiency (as determined by Doppler ABI), uncontrolled congestive heart failure (CHF), vasculitis, uncontrolled diabetes mellitus.
Severe contact dermatitis (allowable if it does not interfere with application of the dressings).
Concomitantly receiving systemic corticosteroids in doses exceeding 20 mg per day.
Involvement in another experimental drug trial within the last month.
Clinical evidence of cellulitis or infection in or around the ulcer.
History of non-compliance to medical regimens and is not considered reliable.
Unable to understand the study evaluations and provide a written informed consent.