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

NCT06729411 | Completed DMC

• 1 other identifier: MOD_2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

diabetic foot; ulcer healing; offloading device; minimal offloading dressing; foot ulcer; healing

Outcome Measures

Primary Outcomes (1)

• Healing rate

  Healing was defined as intact skin at the foot-ulcer site with complete epithelialization and no drainage

  12-weeks

Secondary Outcomes (3)

• Minor amputation

  6 months

• Major amputation

  6 months

• Transfer lesions

  12-weeks

Study Arms (2)

The experimental group received minimal offloading dressing (MOD) treatments

EXPERIMENTAL

The MOD device was a monolayer device that can be applied directly to the participants skin via a non-irritative adhesive backing. The MOD was made of medium-density ethyl-vinyl acetate (40-45° Shore A hardness and 250-400-kg/cm2 density). The MOD is predesigned for three different locations: the first metatarsal head, central metatarsal heads, and fifth metatarsal. The MOD size ranged from size 35 to 48, which is measured according to the French system for each increase of 6.66 mm in length and 1.5 mm in width. All edges of the MOD were bevelled, and apertures were made to accommodate sites of plantar DFUs.

Device: Minimal Offloading dressing

The control group received 15-mm felted foam treatments

ACTIVE COMPARATOR

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.

Device: Felted foam

Interventions

Felted foam DEVICE

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.

The control group received 15-mm felted foam treatments

Minimal Offloading dressing DEVICE

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.

The experimental group received minimal offloading dressing (MOD) treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or 2 diabetes mellitus.
• Age \>18 years,
• Plantar DFU with Texas classification IA or IIA.
• Glycaemic control confirmed by a haemoglobin A1c ≤ 10% (85.8 mmol/mol) in the previous 3 months.

You may not qualify if:

• Critical limb ischaemia as defined by the Trans-Atlantic Inter-Society Consensus II guidelines.
• Active DFU in the contralateral limb, major amputation (below or above the knee) of the contralateral limb.
• Soft tissue infection.
• Untreated diabetic foot osteomyelitis.
• Need for walking aids.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Diabetic Foot Unit. Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

• Lazaro-Martinez JL, Garcia-Madrid M, Molines-Barroso RJ, Alvaro-Afonso FJ, Tardaguila-Garcia A, Lopez-Moral M. Clinical Efficacy of a Novel Minimal Offloading Dressing for the Treatment of Plantar Diabetes-Related Foot Ulcers: A Pilot Randomized Controlled Clinical Trial. Adv Skin Wound Care. 2026 Apr 1;39(3):152-158. doi: 10.1097/ASW.0000000000000413. Epub 2026 Feb 19.

  PMID: 41718581 DERIVED

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 30, 2024
• Last Updated: December 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)