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Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients. A Phase I Pilot Study.

NCT05595681•Cell to Cure ApS

Summary

The STEMFOOT Pilot Study is a single center randomized open phase I clinical intervention pilot trial with the aim of investigating the treatment effect of an allogenic adipose-derived mesenchymal stromal cell product (C2C\_ASC) compared to conventional optimal treatment on healing and complications of foot ulcers in diabetes patients.

Detailed Description

The STEMFOOT Pilot Study will be performed at Copenhagen Diabetes Foot Center, Department of Endocrinology, Bispebjerg Hospital, Denmark. 30 adult patients with diabetes and foot ulcer will be enrolled and randomly assigned 1:1 to either C2C\_ASC treatment on top of standard care (n=15) or control group with standard care (n=15). C2C\_ASC treatment: 1 ml containing 20 x 106 C2C\_ASCs will be injected into the subcutaneous dermo-epidermal junction and homogenously around the wound (4 - 6 injections), but not directly within the index foot ulcer. The depth from the index wound border will be 0,5 - 1 cm into the subcutaneous tissue. Standard care: Each treatment will be administered in the context of independently-managed standard of care, including (a) formal assessment of the ulcer and surrounding skin at each clinic review; (b) provision of any necessary off-loading, with detailed description of the type and assessment of its effectiveness; (c) debridement of the wound surface, which can be surgical (either in the clinic or in an operating room) or non-surgical; (d) selection of appropriate dressing products, ensuring a moist ulcer environment; (e) management of ulcer infection; (f) attention to nutrition and self-care; (g) optimization of glycemic and risk factor control; (h) revascularization when appropriate and (i) continued close observation with appropriate adjustment of management. We hypothesize that in diabtes patients with foot ulcer, the time to healing is significantly shorter and more foot ulcers are completely healed at week 12 when treated with C2C\_ASC on top of standard care compared to control.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of diabetes mellitus for at least 3 months.
•Age 40-75 years.
•A foot ulcer below the level of the malleoli, excluding ulcers confined to the digits or interdigital cleft. If more than one ulcer, the largest will be selected at screening as the index ulcer.
•Wound area after sharp debridement of ≥ 50 mm\^2, but ≤1000 mm\^2.

Exclusion Criteria

•Signs of infection of the index ulcer.
•An ulcer where a probe investigation indicates ulcer depth to the underlying bone.
•Wound caused primarily by untreated vascular insufficiency, or where participants are primarily eligible for vascular intervention to promote wound healing.
•Wounds with an etiology not related to diabetes.
•Underlying osteomyelitis of the leg with the wound to be treated.
•Participants presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
•Surgery to lengthen achilles tendon on the leg with the wound to be treated 3 months prioer to signing the informed consent form.
•Necrosis, purulence, or sinus tracts that cannon be removed by debridement on foot to be treated.
•Toe blood pressure \< 44 mmHg at the foot with the index ulcer.
•Dialysis or an estimated glomerular filtration rate (GFR) (based on serum creatinine) \< 20 ml/min/1.73 m\^2.
+11 more criteria

Locations (1)

Copenhagen Diabetes Foot Center (CODIF)

Copenhagen, Denmark

Key Dates

Start Date

December 15, 2022

Primary Completion Date

November 28, 2025

Completion Date

November 28, 2025

Last Updated

December 23, 2025

Enrollment

ACTUAL participants

Conditions

Diabetic Foot UlcerMesenchymal Stromal Cells

Interventions

Adipose tissue derived mesenchymal stromal/stem cells (Cell2Cure®)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

Inclusion Criteria

Exclusion Criteria

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

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Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)

Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers