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

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

September 1, 2024

Study Completion Date

September 30, 2024

Conditions
Diabetic Foot UlcerOffloading
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.

Trial Locations (1)

28040

Diabetic Foot Unit. Universidad Complutense de Madrid, Madrid

All Listed Sponsors
lead

Universidad Complutense de Madrid

OTHER

NCT06729411 - Minimal Offloading Dressing for the Treatment of Plantar Diabetes-related Foot Ulcers | Biotech Hunter | Biotech Hunter