Biotec BetaGlycans AS; WOULGAN BIOGEL; WBG-03
Research type
Research Study
Full title
Evaluation of WOULGAN® in diabetic foot ulcer compared with a commercial hydrogel.
IRAS ID
193933
Contact name
Rolf Engstad
Contact email
Sponsor organisation
Biotech BioGlucans AS, a subsidiary of Biotec Pharmacon ASA
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
During the process of CE marking of Woulgan® Biogel it was agreed with the Competent Authority of the UK (Medicines & Healthcare products Regulatory Agency, MHRA) to perform a Post Marked Clinical Follow-up study when the CE-mark was issued in order to assess the safety and usefulness of the product in treatment of wounds.
The approved intended use for Woulgan® Biogel is as a primary dressing for dry to low exuding partial and full thickness dermal wounds, including diabetic ulcers, pressure ulcers, leg ulcers, graft and donor sites, postoperative surgical wounds, trauma wounds, 1st and 2nd degree burns, abrasions and lacerations.
The current study thus aims at providing data from diabetic foot ulcers, which is considered the most difficult wound to heal of the above, to support the safety and efficacy of Woulgan® Biogel in relation to a commercially available hydrogel.
Woulgan® Biogel is a sterile wound gel for single use, single patient, to be used under the supervision of health care professionals and primarily in hospitals or care units.
At least 80 evaluable participants with diabetic foot ulcer will be recruited and randomised as 20 to commercial hydrogel and 60 to Woulgan® Biogel. The study will be conducted at PG/University/NHS sites in England.
It is planned to include the first patient in the study in the beginning of January 2016. The last patient is planned to have completed the study by the end of May 2016.
At each study visit, participants will undergo treatment, photos are taken of the ulcer and the patients are being asked questions, mainly regarding dressing changes, medication and pain. In addition, the following will be recorded on the first study visit: Demographics, Ankle-Brachial Pressure Index, Smoking habits and previous wound therapy.REC name
North West - Preston Research Ethics Committee
REC reference
16/NW/0116
Date of REC Opinion
24 Feb 2016
REC opinion
Further Information Favourable Opinion