Evaluation of Woulgan in Diabetic Foot Ulcer

Overview

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.

Full Title of Study: “Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Interventions

  • Device: Woulgan Gel
    • Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
  • Device: Intrasite Hydrogel
    • Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage

Arms, Groups and Cohorts

  • Other: Woulgan Gel
    • Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
  • Other: Intrasite Hydrogel
    • Primary dressing with Intrasite Hydrogel

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events
    • Time Frame: 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).
    • Time Frame: Until 8 weeks from start of treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biotec Pharmacon ASA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Magnus Londahl, MD, PhD, Principal Investigator, Skane University Hospital

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