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NCT04058639 Clinical Trial

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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04058639
Other study ID # 2019/266
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 1, 2024

Study information
Verified date September 2023
Source Helse Møre og Romsdal HF
Contact Ida Gule
Phone +47 71121926
Email Ida.Gule@helse-mr.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 74
Est. completion date June 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• "custom felt relief"
Felt is adjusted to the wound by cutting it in different ways and layers once every week
• standard relief treatment
Felt in the shape of a letter U is put around the wound once every week.

Locations
Country Name City State
Norway Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF Molde

Sponsors (1)
Lead Sponsor Collaborator
Helse Møre og Romsdal HF

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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