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NCT Number: NCT02631512

Evaluation of Woulgan in Diabetic Foot Ulcer

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.

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Key information

Conditions

Diabetic Foot Ulcers Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skaane University Hospital, Lund, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Woulgan Gel

Device

Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.

Intrasite Hydrogel

Device

Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Biotec Pharmacon ASA

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Dec 16, 2015
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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