Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: "custom felt relief", standard relief treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure "custom felt relief"
Felt is adjusted to the wound by cutting it in different ways and layers once every week - Procedure standard relief treatment
Felt in the shape of a letter U is put around the wound once every week.
Primary outcome measures
- wound healing time in weeks [Time frame: 2-8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF — Molde
Identifiers
NCT: NCT04058639 · 2019/266