ChloraSolv03, Version 01
Research type
Research Study
Full title
An open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv® on pressure ulcers in need of debridement
IRAS ID
320237
Contact name
Caroline Gröndahl
Contact email
Sponsor organisation
RLS Global AB
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CSC 108792, MHRA Reference number; CIV-22-06-039730, CIV-ID; DERM 54980, CPMS ID
Duration of Study in the UK
0 years, 11 months, 29 days
Research summary
ChloraSolv03 is a multicentre investigation to evaluate the efficacy and safety of ChloraSolv in the treatment of pressure ulcers in need of debridement.
For a hard-to-heal wound such as pressure ulcers to heal, the conditions need to be the best. By removing the dead tissue on the wound (debride), the healthy tissue can grow and provide good conditions for a better wound healing. A common way to remove dead wound tissue is with a sharp instrument under anaesthesia.
RLS Global, which is the Swedish company responsible for the investigation, has developed the product ChloraSolv. ChloraSolv is a gel that is approved for use on hard-to-heal diabetic foot ulcers and leg ulcers in need of debridement. The gel is applied directly on the wound and it immediately softens dead tissue (necrosis) and biofilm that after just a couple of minutes can be removed by healthcare professionals with a blunt instrument. Underlying and surrounding healthy tissue is not affected by the gel. You may need pain relief before treatment since any touch of a pressure ulcer can be painful.
The investigation will be conducted at clinics in Sweden, UK and Finland and have a total of 54 participants. Each participating patient will complete 3-14 study-specific visits. The number of visits depends on how quickly the wound becomes clean from dead tissue. Patients will visit the clinic 1 - 2 times a week and the total duration of treatment can reach a maximum of 12 weeks. The goal of the investigation is to evaluate the proportion of clean wounds during the treatment period.
After a maximum of 12 weeks of treatment, the patient is scheduled for a follow-up visit 6 weeks after end of treatment.
Participation is voluntary and the patient may discontinue his or her participation in the investigation at any time. Participation in the investigation does not entail any costs for the patient. No sampling will take place.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0270
Date of REC Opinion
31 Mar 2023
REC opinion
Further Information Favourable Opinion