Diabetic Foot Ulcers: Shorter Treatment Period Using Cust... | NCT04058639

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

NCT04058639

Sponsor

Helse Møre og Romsdal HF

Status

Recruiting

Last Update Posted

Mar 14, 2025Actual

Enrollment

74Estimated

Phase

Not Applicable

Conditions

Diabetic Foot Ulcer

Interventions

"custom felt relief"
standard relief treatment

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Mar 1, 2026Estimated

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Aug 14, 2019

First Submission Date that Met QC Criteria

Aug 14, 2019

First Posted Date

Aug 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2025

Last Update Posted Date

Mar 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
felt relief	Experimental	"custom felt relief"	Procedure: "custom felt relief"
treatment as usual	Active Comparator	standard treatment usually provided by the Surgical Outpatient Clinic	Procedure: standard relief treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"custom felt relief"	Procedure	Felt is adjusted to the wound by cutting it in different ways and layers once every week	felt relief

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ida Gule	Contact	+47 71121926		Ida.Gule@helse-mr.no
Anne Marie Haag-Kvernberg, md	Contact

Overall Officials

Name	Affiliation	Role
Tone Seim Fuglset, phd	Helse Møre og Romsdal HF	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikk for Kirurgi Molde, Helse Møre og Romsdal HF	Recruiting	Molde			Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided