Evaluation of Woulgan in Diabetic Foot Ulcer

Phase 4

Completed

• Conditions: Diabetic Foot Ulcers
• Interventions: Device: Woulgan Gel; Device: Intrasite Hydrogel

• Registration Number: NCT02631512
• Lead Sponsor: Biotec Pharmacon ASA

Brief Summary

The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite. Healing and untoward medical events to be evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-12-12
• Study First Posted: 2015-12-16
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-28
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Type I or II diabetes mellitus.
• Target ulcer area between 0.5 and 5 sqcm, and more than 4 weeks old.
• Ankle-brachial pressure index above 0.7.

Exclusion Criteria

• Ulcers due to non-diabetic etiology.
• Uncontrolled diabetes defined as HbA1c above 70 mmol/mol and insufficient nutritional status.
• Ulcers older than 1 year.
• Any of gangrene, osteomyelitis, cellulitis, or Charcot osteoarthropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Woulgan Gel	Woulgan Gel	Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
Intrasite Hydrogel	Intrasite Hydrogel	Primary dressing with Intrasite Hydrogel

Primary Outcome Measures

Name	Time	Method
Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.	Until 8 weeks from start of treatment

Secondary Outcome Measures

Name	Time	Method
Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events	Until 8 weeks from start of treatment
Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS).	Until 8 weeks from start of treatment

Trial Locations

Locations (3)

Skaane University Hospital; 🇸🇪 Lund, Sweden

Nottingham University Hospital; 🇬🇧 Nottingham, United Kingdom

North Middlesex University Hospital; 🇬🇧 London, United Kingdom