Factorial4VLU: Exercise or dilute hypochlorous acid for venous leg ulcers: a factorial randomised trial

Phase 3

Completed

• Conditions: Skin - Other skin conditions; Venous leg ulceration; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12620000116921
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-07
• Study Completion: 2022-04-29
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

Aged 18 years or older, determined to have a VLU (clinical indications of venous ulceration, Ankle Brachial Index greater than or equal to 0.8, and other causative aetiologies ruled out), able to tolerate compression therapy, able to provide written informed consent, and able to walk safely independently (aids allowed).

Exclusion Criteria

Have hypersensitivity to hypopchlorous acid or sodium hypochlorite, have a fixed ankle joint, have VLU with current infection (may be eligible once infection cleared), have VLU with exposed bone or tendon, have history of rheumatoid arthritis or vasculitis, have uncontrolled diabetes (HbA1c > 100), have severe liver, heart, or renal failure, have severe peripheral arterial disease, have suspected or diagnosed skin malignancy associated with the leg ulcer, or have any other threat to safe participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of participants with complete healing of reference ulcer as adjudicated by blinded review of ulcer photographs. Complete healing is defined as full epithelialisation of the ulcer with no scab.[12 weeks after randomisation ]