Chemical debridement and leg ulcers v.1.0
Research type
Research Study
Full title
A pilot study to investigate the relative effectiveness and safety of chemical wound debridement and curettage in the treatment of venous and mixed aetiology leg ulcers
IRAS ID
347678
Contact name
Jeffery
Contact email
Sponsor organisation
DEBx Medical B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 1 days
Research summary
Wound cleansing (debridement) is one of the most important elements of wound healing therapy. There are many techniques for wound cleansing. These include methods where the wound is cleansed mechanically using an instrument, and methods where a chemical solution is applied on the wound. Unfortunately, most of the cleansing techniques can be very painful and should be performed under local or general anaesthesia. Some methods also require special devices and skills of the performer. There is a need for safe techniques which can be easily performed by clinicians and cause minimal discomfort to the patients.
This pilot study will investigate the effectiveness and safety of two wound cleansing methods:
1) chemical cleansing using a novel gel, DEBRICHEM®, which removes water and bacteria from the wound, and
2) mechanical cleansing using an instrument called a curette to scrape off dead tissue.This will be the first randomised study with DEBRICHEM®. In addition to assessing clinical effectiveness and safety, we will assess patient-reported quality of life and pain, and patient and staff acceptance for both cleansing methods.
The study will recruit in total 40 adult participants with chronic leg wounds. Participants will be recruited through the Pioneer Wound Healing and Lymphoedema Centres, UK. Each participant will be in the study for 12 weeks during which there will be 4-5 visits. At each visit, the wound will be undressed, cleansed using one of the two methods and assessed. A photograph of the wound will be taken at each visit to assess the change in wound size. Participants will also be asked to complete questions about their quality of life and pain. The study will run from November 2024 until May 2024 (last patient last visit).
The study is funded by DEBx Medical B.V. (Netherlands).
REC name
London - Dulwich Research Ethics Committee
REC reference
24/LO/0775
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion