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

NCT04058639 | Recruiting

• 1 other identifier: 2019/266
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer

Keywords

Bandages; Wound Healing; Time; Relief

Outcome Measures

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

  2-8 weeks

Study Arms (2)

felt relief

EXPERIMENTAL

"custom felt relief"

Procedure: "custom felt relief"

treatment as usual

ACTIVE COMPARATOR

standard treatment usually provided by the Surgical Outpatient Clinic

Procedure: standard relief treatment

Interventions

"custom felt relief" PROCEDURE

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

felt relief

standard relief treatment PROCEDURE

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

treatment as usual

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead

Study Sites (1)

Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF

Molde, Norway

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Tone Seim Fuglset, phd

  Helse Møre og Romsdal HF

  STUDY DIRECTOR

Central Study Contacts

Ida Gule

CONTACT

+47 71121926; Ida.Gule@helse-mr.no

Anne Marie Haag-Kvernberg, md

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: block randomization

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: October 1, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)