Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorHelse Møre og Romsdal HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with Diabetes Mellitus Type 1 or 2
has neuropathic wounds under the foot
understands and speaks Norwegian well
competent to give consent
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
"custom felt relief"
Procedure/SurgeryFelt is adjusted to the wound by cutting it in different ways and layers once every week
standard relief treatment
Procedure/SurgeryFelt in the shape of a letter U is put around the wound once every week.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: felt reliefExperimental treatment 1 intervention
Group B: treatment as usualActive comparator 1 intervention
Trial outcomes
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
Time frame
2-8 weeksSponsors and contacts
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Source ClinicalTrials.gov