Diabetic Foot UlcerNCT04058639
Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
A study testing "custom felt relief" and standard relief treatment in people with Diabetic Foot Ulcer, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- "custom felt relief" and standard relief treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2019to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with Diabetes Mellitus Type 1 or 2
- has neuropathic wounds under the foot
- understands and speaks Norwegian well
- competent to give consent
Who cannot join
- responds to the filament glue and/or the tape used in treatment
- in need of vascular surgery intervention
- to be admitted to the hospital
- in need of intravenously administered antibiotics due to wound infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Marie Haag-Kvernberg, md contact
Norway1 site, 1 recruiting
- Recruiting
Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF
Molde
Ida Gule, +47 71121926, Ida.Gule@helse-mr.no
About this study
The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results.
Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- "custom felt relief", standard relief treatment
- Keywords
- Bandages, Wound Healing, Time, Relief
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"custom felt relief"Procedure or surgery
Felt is adjusted to the wound by cutting it in different ways and layers once every week
standard relief treatmentProcedure or surgery
Felt in the shape of a letter U is put around the wound once every week.
| Study group | Role | What they receive |
|---|---|---|
| felt relief | Experimental | "custom felt relief" Receives: Procedure: "custom felt relief" |
| treatment as usual | Active comparator | standard treatment usually provided by the Surgical Outpatient Clinic Receives: Procedure: standard relief treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing time in weeks
from the patients first visit (when the first felt dressing is applied) until the wound is healed
Measured: 2-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Oct 2019
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- block randomization
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tone Seim Fuglset, phd, Study director, Helse Møre og Romsdal HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058639
- Sponsor's protocol ID
- 2019/266
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2019
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
- ClinicalTrials.gov ID
- NCT04058639
- Acronym / sponsor ID
- 2019/266
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Bandages, Wound Healing, Time, Relief
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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 Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results.
Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- block randomization
| Arm | Type | Receives |
|---|---|---|
| felt relief | Experimental | Procedure: "custom felt relief""custom felt relief" |
| treatment as usual | Active comparator | Procedure: standard relief treatmentstandard treatment usually provided by the Surgical Outpatient Clinic |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosed with Diabetes Mellitus Type 1 or 2
- has neuropathic wounds under the foot
- understands and speaks Norwegian well
- competent to give consent
Key exclusion criteria (4 listed)
- responds to the filament glue and/or the tape used in treatment
- in need of vascular surgery intervention
- to be admitted to the hospital
- in need of intravenously administered antibiotics due to wound infection.
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 |
|---|---|---|
| "custom felt relief"Felt is adjusted to the wound by cutting it in different ways and layers once every week | Procedure or surgery | felt relief |
| standard relief treatmentFelt in the shape of a letter U is put around the wound once every week. | Procedure or surgery | treatment as usual |
Primary outcome
wound healing time in weeks
Time frame: 2-8 weeks
from the patients first visit (when the first felt dressing is applied) until the wound is healed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Anne Marie Haag-Kvernberg, md contact
Tone Seim Fuglset, phd study director
Helse Møre og Romsdal HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "custom felt relief" and standard relief treatment in people with Diabetic Foot Ulcer, run by Helse Møre og Romsdal HF at 1 site in Norway.
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 4 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ida Gule (+47 71121926, Ida.Gule@helse-mr.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing time in weeks (time frame: 2-8 weeks). 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 14 Aug 2026.