Back to resultsEvaluation of Woulgan in Diabetic Foot Ulcer
Primary Purpose
Diabetic Foot Ulcers
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Woulgan Gel
Intrasite Hydrogel
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcers
Eligibility Criteria
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.
Sites / Locations
- Skaane University Hospital
- North Middlesex University Hospital
- Nottingham University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Woulgan Gel
Intrasite Hydrogel
Arm Description
Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
Primary dressing with Intrasite Hydrogel
Outcomes
Primary Outcome Measures
Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.
Secondary Outcome Measures
Safety of Woulgan Gel as primary dressing in diabetic foot ulcer measured in terms of untoward medical events
Useability of Woulgan as primary dressing in diabetic foot ulcer measured as degree of pain (100 mm VAS).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02631512
Brief Title
Evaluation of Woulgan in Diabetic Foot Ulcer
Official Title
Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotec Pharmacon ASA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Woulgan Gel
Arm Type
Other
Arm Description
Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG)
Arm Title
Intrasite Hydrogel
Arm Type
Other
Arm Description
Primary dressing with Intrasite Hydrogel
Intervention Type
Device
Intervention Name(s)
Woulgan Gel
Intervention Description
Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
Intervention Type
Device
Intervention Name(s)
Intrasite Hydrogel
Intervention Description
Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Londahl, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skaane University Hospital
City
Lund
ZIP/Postal Code
S-22185
Country
Sweden
Facility Name
North Middlesex University Hospital
City
London
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG72UH
Country
United Kingdom
12. IPD Sharing Statement
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Evaluation of Woulgan in Diabetic Foot Ulcer
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