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NCT Number: NCT04058639

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

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.

Recruiting

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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF

Molde, Norway

Location status: Recruiting

Location contact

Ida Gule

CONTACT

[email protected]

+47 71121926

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

"custom felt relief"

Procedure

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

standard relief treatment

Procedure

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Marie Haag-Kvernberg, md

CONTACT

Ida Gule

CONTACT

[email protected]

+47 71121926

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2019
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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