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

H

Helse Møre og Romsdal HF

Status

Enrolling

Conditions

Diabetic Foot Ulcer

Treatments

Procedure: standard relief treatment
Procedure: "custom felt relief"

Study type

Interventional

Funder types

Other

Identifiers

NCT04058639
2019/266

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

felt relief
Experimental group
Description:
"custom felt relief"
Treatment:
Procedure: "custom felt relief"
treatment as usual
Active Comparator group
Description:
standard treatment usually provided by the Surgical Outpatient Clinic
Treatment:
Procedure: standard relief treatment

Trial contacts and locations

1

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Central trial contact

Ida Gule; Anne Marie Haag-Kvernberg, md

Data sourced from clinicaltrials.gov

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