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
Summary of Research
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).
Summary of Results
Study 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
Wound debridement, or cleansing, is one of the most important elements of wound healing therapy. This pilot study investigated the effectiveness and safety of two wound debridement methods:
1) chemical debridement using a novel gel, DEBRICHEM®, which removes water and bacteria from the wound, and
2) mechanical debridement by curettage, which uses an instrument called a curette to scrape off dead tissue.In addition to assessing clinical effectiveness and safety, we assessed patient-reported quality of life and pain, and collected patient and staff comments for both cleansing methods.
Eighty-six participants with chronic leg wounds were recruited through the Pioneer Wound Healing and Lymphoedema Centres, UK. Each participant was in the study for 12 weeks during which there were 4-5 visits: a baseline visit, visits at weeks 4, 8 and 12, and a week 2 visit which was optional in the curettage group. The study was conducted between November 2024 and September 2025.
At baseline visit, participants were randomly allocated to one of the two treatment groups: DEBRICHEM® or curettage. The wound was then debrided using the allocated method and assessed. A photograph of the wound was taken to assess wound size. Participants were also asked to complete questions about their quality of life and pain.
At each following visit, the wound was undressed, debrided using standard methods and assessed. A photograph of the wound was taken to assess the change in wound size, and questions about quality of life and pain were completed.
The study had two primary objectives: to assess the change in wound surface area from baseline until week 12 of treatment and to assess changes in the proportion of the wound bed covered with soft dead tissue over the same time period.
We found that both techniques produced similar changes in wound area and dead tissue cover suggesting that there was no clear superiority of one technique over the other. Quality of life improved in both groups. One difference was noted between the two groups at baseline: pain after cleansing was higher among the group who received DEBRICHEM® and this finding was supported by the frequent reference to pain in participant comments. Both treatments were found to be safe and no serious side effects were reported.
Our results suggest that DEBRICHEM® may be as effective as curettage in wound cleansing. Compared with curettage, it may offer practical advantages as it does not require as much skill as curettage. The potential economic benefits of DEBRICHEM® require testing in an appropriate health economic study.
As this was a pilot study, we did not perform any formal statistical testing to compare data between the two groups. Larger studies will be required to confirm our findings. Our study also raises a question if a longer application of an anaesthetic cream before debridement could reduce pain after DEBRICHEM® use. This should be tested in future studies.
Results from this study will be published in a peer-reviewed journal and reported on the Pioneer website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpioneer-whlc.co.uk%2F&data=05%7C02%7Cdulwich.rec%40hra.nhs.uk%7C3035566b26434696fd0b08df07feb9c2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639238462763115805%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=3SCKMXChHE%2FqE9%2F2N4RanWIFK7cbR75uUn%2F0Fzt5qYs%3D&reserved=0) and on Clinicaltrials.gov (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclinicaltrials.gov%2F&data=05%7C02%7Cdulwich.rec%40hra.nhs.uk%7C3035566b26434696fd0b08df07feb9c2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639238462763163723%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ggyoqINVtZww4dAxE4OMRIb99u8w6p5MtkjRcnZiMcY%3D&reserved=0).
The study was funded and sponsored 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