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Minimal Offloading Dressing for the Treatment of Plantar Diabetes-related Foot Ulcers

NCT06729411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-17

No results posted yet for this study

Summary

A monocentre randomized controlled parallel (1:1) clinical trial was performed with consecutively selected individuals with diabetes and active diabetes-related foot ulcers (DFU). Participants were randomly assigned to control or treatment groups. The experimental group received MOD treatments, and the control group received 15-mm felted foam treatments. All participants wore a removable ankle-high offloading device.

Primary outcome measure was the 12-week healing rate. The time to healing was evaluated during a 12-week follow-up period. The secondary outcome measures included minor or major amputations related to the DFU during a follow-up period of 6 months.

Conditions

  • Diabetic Foot Ulcer
  • Offloading

Interventions

DEVICE

Minimal Offloading dressing

Metatarsal minimal offloading dressings (MODs) are standard offloading devices that are gaining attention. MODs offload a specific ulcerated area and could reduce variability when applying the device onto the skin. MODs are new predesigned devices that do not require any further adaptation or clinician skills and can be directly applied to an ulcerated metatarsal head using a non-irritating adhesive.

DEVICE

Felted foam

The felted padding used in the control group was made out of semi-compressed wool felt with an adhesive backing (Herbitas lab, 46134 Foios-Valencia, Spain). The padding thickness was 15 mm on the whole foot, and similar apertures to those used with the other offloading device were made to accommodate the sites of plantar ulceration.

Sponsors & Collaborators

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-09-01
Completion
2024-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729411 on ClinicalTrials.gov