CLINICAL TRIAL OF LARVAL THERAPY IN PATIENTS WITH LEG ULCERS

• Conditions: Venous or mixed venous/arterial ulcers; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-001284-44-HU
• Lead Sponsor: MAGGOT 2006 Egészségügyi, Kereskedelmi és Szolgáltató Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male and female patients aged between 18 and 85 years inclusive with venous or mixed venous/arterial ulcers
•Minimum ankle brachial pressure index (ABPI) equal to or more than 0.8
•Minimum of 25% of ulcer area covered by slough and/or necrotic tissue
•Patients with ulcers with an area of (30-70) cm2 (and the ulcer was not healing (‘not healing’ defined as no measurable change in area over one month preceding assessment). The ulcer for larval and hydrogel terapy could be selected from one leg or both legs. One of the ulcers will serve for larval therapy: ” reference ulcer” and the other one for Hydrogel therapy: ”control ulcer”.
•Patients with at least two ulcers with an area of 30-70 cm2 (using one ulcer for active and one for control hydrogel treatment); within each patient the difference between two ulcers should not exceed 10 cm2.
•Male patients
•Female patients must either be
-Post menopausal
-Surgically sterile
-Use an accepted contraceptive method such as the contraceptive pill
•Able to provide written informed consent prior to study participation
•Able to communicate well with the investigator and comply with the study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Lactation, pregnancy or women of childbearing potential not practising an adequate method of contraception, such as oral contraception
•Hypersensitivity to hydrogel
•Diabetic patients under inappropriate control (HbA1C more than 10)
•Participation in a clinical trial within 1 month before start of the trial
•Patients with grossly oedematous legs, which in the opinion of the recruiting health care professional, are unsuitable for treatment with larval therapy and/or hydrogel
•Patients on anticoagulants (e.g. warfarin)
•Recent treatment with topical silver products within one month
•Recent treatment with oral or topical metronidazole within one month
•Subject is unable to understand and comply with protocol requirements and instructions and is unlikely to complete the study as planned.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified