Evaluation of Woulgan in Diabetic Foot Ulcer

Biotec Pharmacon ASA62 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Foot Ulcers

Interventions

Woulgan GelDEVICE

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

Intrasite HydrogelDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Skaane University Hospital

Lund, Sweden

North Middlesex University Hospital

London, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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