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

NCT ID: NCT04058639

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

block randomization
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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felt relief

"custom felt relief"

Group Type EXPERIMENTAL

"custom felt relief"

Intervention Type PROCEDURE

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

treatment as usual

standard treatment usually provided by the Surgical Outpatient Clinic

Group Type ACTIVE_COMPARATOR

standard relief treatment

Intervention Type PROCEDURE

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

Interventions

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"custom felt relief"

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

Intervention Type PROCEDURE

standard relief treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tone Seim Fuglset, phd

Role: STUDY_DIRECTOR

Helse Møre og Romsdal HF

Locations

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Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF

Molde, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Ida Gule

Role: CONTACT

+47 71121926

Anne Marie Haag-Kvernberg, md

Role: CONTACT

Facility Contacts

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Ida Gule

Role: primary

+47 71121926

Other Identifiers

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2019/266

Identifier Type: -

Identifier Source: org_study_id

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