Evaluation of Woulgan in Diabetic Foot Ulcer

Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Device: Woulgan Gel; Device: Intrasite Hydrogel

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, S-22185
    • Skaane University Hospital
• United Kingdom
  • London, United Kingdom, N18 1QX
    • North Middlesex University Hospital
  • Nottingham, United Kingdom, NG72UH
    • Nottingham University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Woulgan Gel; Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)	Device: Woulgan Gel; Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
Other: Intrasite Hydrogel; Primary dressing with Intrasite Hydrogel	Device: Intrasite Hydrogel; Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biotec Pharmacon ASA
• Investigators: Principal Investigator: Magnus Londahl, MD, PhD, Skane University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: December 12, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 28, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: WBG-03