Evaluation of Woulgan in Diabetic Foot Ulcer

Diabetic Foot Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631512
• Other study ID #: WBG-03
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Biotec Pharmacon ASA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Sweden	Skaane University Hospital	Lund
United Kingdom	North Middlesex University Hospital	London
United Kingdom	Nottingham University Hospital	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Biotec Pharmacon ASA

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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