Evaluation of Woulgan in Diabetic Foot Ulcer

Biotec Pharmacon

Status and phase: Completed; Phase 4

Conditions: Diabetic Foot Ulcers

Treatments: Device: Intrasite Hydrogel; Device: Woulgan Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02631512

WBG-03

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Woulgan Gel

Other group

Description:

Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)

Treatment:

Device: Woulgan Gel

Intrasite Hydrogel

Other group

Description:

Primary dressing with Intrasite Hydrogel

Treatment:

Device: Intrasite Hydrogel