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

September 1, 2023 updated by: Helse Møre og Romsdal HF

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Anne Marie Haag-Kvernberg, md

Study Locations

  • Norway
      • Molde, Norway
        • Recruiting
        • Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: felt relief
"custom felt relief"
Procedure: "custom felt relief"
Felt is adjusted to the wound by cutting it in different ways and layers once every week
Active Comparator: treatment as usual
standard treatment usually provided by the Surgical Outpatient Clinic
Procedure: standard relief treatment
Felt in the shape of a letter U is put around the wound once every week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Møre og Romsdal HF

Investigators

  • Study Director: Tone Seim Fuglset, phd, Helse Møre og Romsdal HF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 14, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Foot Ulcer

Clinical Trials on "custom felt relief"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe