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

Primary Purpose

Diabetic Foot Ulcer

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
"custom felt relief"
standard relief treatment
Sponsored by
Helse Møre og Romsdal HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Bandages, Wound Healing, Time, Relief

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Klinikk for Kirurgi Molde, Helse Møre og Romsdal HFRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

felt relief

treatment as usual

Arm Description

"custom felt relief"

standard treatment usually provided by the Surgical Outpatient Clinic

Outcomes

Primary Outcome Measures

wound healing time in weeks
from the patients first visit (when the first felt dressing is applied) until the wound is healed

Secondary Outcome Measures

Full Information

First Posted
August 14, 2019
Last Updated
September 1, 2023
Sponsor
Helse Møre og Romsdal HF
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1. Study Identification

Unique Protocol Identification Number
NCT04058639
Brief Title
Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
Official Title
Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Møre og Romsdal HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Bandages, Wound Healing, Time, Relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
block randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
felt relief
Arm Type
Experimental
Arm Description
"custom felt relief"
Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
standard treatment usually provided by the Surgical Outpatient Clinic
Intervention Type
Procedure
Intervention Name(s)
"custom felt relief"
Intervention Description
Felt is adjusted to the wound by cutting it in different ways and layers once every week
Intervention Type
Procedure
Intervention Name(s)
standard relief treatment
Intervention Description
Felt in the shape of a letter U is put around the wound once every week.
Primary Outcome Measure Information:
Title
wound healing time in weeks
Description
from the patients first visit (when the first felt dressing is applied) until the wound is healed
Time Frame
2-8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ida Gule
Phone
+47 71121926
Email
Ida.Gule@helse-mr.no
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Marie Haag-Kvernberg, md
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tone Seim Fuglset, phd
Organizational Affiliation
Helse Møre og Romsdal HF
Official's Role
Study Director
Facility Information:
Facility Name
Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF
City
Molde
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ida Gule
Phone
+47 71121926
Email
Ida.Gule@helse-mr.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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