Evaluation of Woulgan in Diabetic Foot Ulcer
1 other identifier
interventional
62
2 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2015
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 9, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedMay 30, 2019
May 1, 2019
3.3 years
November 9, 2015
May 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
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
Study Arms (2)
Woulgan Gel
OTHERPrimary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
Intrasite Hydrogel
OTHERPrimary dressing with Intrasite Hydrogel
Interventions
Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Skaane University Hospital
Lund, S-22185, Sweden
North Middlesex University Hospital
London, N18 1QX, United Kingdom
Nottingham University Hospital
Nottingham, NG72UH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Londahl, MD, PhD
Skane University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2015
First Posted
December 16, 2015
Study Start
October 1, 2015
Primary Completion
December 31, 2018
Study Completion
April 30, 2019
Last Updated
May 30, 2019
Record last verified: 2019-05