Diabetic Foot UlcersPhase 4NCT02631512
Evaluation of Woulgan in Diabetic Foot Ulcer
A Phase 4 study testing Woulgan Gel and Intrasite Hydrogel in people with Diabetic Foot Ulcers, run by Biotec Pharmacon ASA at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Woulgan Gel and Intrasite Hydrogel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2015to 30 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
North Middlesex University Hospital
London, N18 1QX
Nottingham University Hospital
Nottingham, NG72UH
About this study
Official title: Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel
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.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Woulgan Gel, Intrasite Hydrogel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Woulgan Gel | Other | Primary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG) Receives: Device: Woulgan Gel |
| Intrasite Hydrogel | Other | Primary dressing with Intrasite Hydrogel Receives: Device: Intrasite Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Woulgan Gel as primary dressing in diabetic foot ulcer in terms of reduced wound size in sqcm.
Measured: 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
Measured: 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).
Measured: Until 8 weeks from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion31 Dec 2018
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotec Pharmacon ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magnus Londahl, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631512
- Sponsor's protocol ID
- WBG-03
- Status last verified
- May 2019
- First submitted
- 9 Nov 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Woulgan in Diabetic Foot Ulcer Compared With a Commercial Hydrogel
- ClinicalTrials.gov ID
- NCT02631512
- Acronym / sponsor ID
- WBG-03
- Conditions
- Diabetic Foot Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Biotec Pharmacon ASAIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Woulgan Gel | Other | Device: Woulgan GelPrimary dressing with Woulgan Gel with Soluble Beta-Glucan (SBG) |
| Intrasite Hydrogel | Other | Device: Intrasite HydrogelPrimary dressing with Intrasite Hydrogel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Woulgan GelPrimary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage. | Device | Woulgan Gel |
| Intrasite HydrogelPrimary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage | Device | Intrasite Hydrogel |
Primary outcome
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
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
Related trials for Diabetic Foot Ulcers
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Londahl, MD, PhD principal investigator
Skane University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Woulgan Gel and Intrasite Hydrogel in people with Diabetic Foot Ulcers, run by Biotec Pharmacon ASA at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.