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RecruitingNCT04058639Updated Aug 14, 2026

Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?

An interventional study of "custom felt relief" and standard relief treatment in Diabetic Foot Ulcer, sponsored by Helse Møre og Romsdal HF. Recruiting at 1 site in Norway. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Helse Møre og Romsdal HF · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Diabetic Foot Ulcer

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Keywords

  • Bandages
  • Wound Healing
  • Time
  • Relief
03

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosed with Diabetes Mellitus Type 1 or 2
  • has neuropathic wounds under the foot
  • understands and speaks Norwegian well
  • competent to give consent

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    felt relief

    "custom felt relief"

    Procedure: "custom felt relief"

  • Active comparator
    treatment as usual

    standard treatment usually provided by the Surgical Outpatient Clinic

    Procedure: standard relief treatment

Interventions

  • Procedure"custom felt relief"

    Felt is adjusted to the wound by cutting it in different ways and layers once every week

  • Procedurestandard relief treatment

    Felt in the shape of a letter U is put around the wound once every week.

05

What researchers measure

Primary outcomes

  1. wound healing time in weeks

    from the patients first visit (when the first felt dressing is applied) until the wound is healed

    Time frame: 2-8 weeks

06

Study locations

1 of 1 sites recruiting
  • Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF
    Molde, Norway
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04058639
Lead sponsor
Helse Møre og Romsdal HF
Responsible party
Sponsor
First posted
Aug 15, 2019
Start date
Oct 1, 2019
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Aug 14, 2026

Study contacts

Ida Gule
Contact
Ida.Gule@helse-mr.no
+47 71121926
Anne Marie Haag-Kvernberg, md
Contact
Tone Seim Fuglset, phd
study director · Helse Møre og Romsdal HF

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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