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Updated: Sep 10, 2025
Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
A single-centre, prospective, randomised controlled pilot trial of different dressing regimens for delayed healing
Leon Jonker1, Emma Mark2, Katie Boichat3
1Science and Innovation Manager, North Cumbria Integrated Care NHS Foundation Trust, Penrith, UK.
Background:
Foot ulcer healing may be impeded because of underlying pathology and/or patient non‑compliance affecting the wound healing process. Healthcare professionals may opt to apply antimicrobial dressings to control bioburden and avert infections, ultimately achieving wound regeneration and repair.
Aims:
The study evaluated and compared the effectiveness of different types of dressing on foot ulcer healing.
Methods:
A single‑centre, prospective, open‑label, randomised, controlled pilot trial was conducted, comparing three treatment arms: a standard non‑antimicrobial dressing; a physical antimicrobial dressing; a rotation regimen of chemical antimicrobial dressings, each applied successively for 2 weeks per rotation. Dressings were applied throughout the trial period, up to 18 weeks or until the ulcer healed, and outcome measures were collated at weeks 0, 3, 6, 9, 12 and 18.
Results:
A total of 40 patients were randomised. After 12 weeks, the median percentage wound size compared to initial foot ulcer size at baseline was 41% for the physical antimicrobial dressing, 35% for the rotation regimen arm and 9% for the non‑antimicrobial dressing (p‑value 0.21, Kruskal‑Wallis test). Out of the initial 14 patients, three required antibiotics in the physical antimicrobial arm, four in the rotation arm and three in the non‑antimicrobial arm. Up to week 6 of the trial period, the intended randomised dressing was applied in 29 out of 33 cases (88%) but treatment deviation increased thereafter.
Conclusions:
Conducting a trial comparing different dressings for foot ulcers poses challenges. Deviation from planned dressing choice, either because of marked improvement or deterioration of the ulcer, systemic antibiotics use and occasional patient non‑compliance can limit generalisability of the findings.
Implications For Practice:
Antimicrobial dressings may promote better foot ulcer healing than standard dressings, though evidence remains inconclusive. Treatment plans should remain flexible to accommodate wound changes and patient compliance.
