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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: "custom felt relief"; Procedure: standard relief treatment

• Registration Number: NCT04058639
• Lead Sponsor: Helse Møre og Romsdal HF

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-14
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-15
• Study Start: 2019-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
felt relief	"custom felt relief"	"custom felt relief"
treatment as usual	standard relief treatment	standard treatment usually provided by the Surgical Outpatient Clinic

Primary Outcome Measures

Name	Time	Method
wound healing time in weeks	2-8 weeks	from the patients first visit (when the first felt dressing is applied) until the wound is healed

Trial Locations

Locations (1)

Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF; 🇳🇴 Molde, Norway