Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot (FOOTCELL)

NCT06843122 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FOOTCELL
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to investigate the safety and efficacy of allogenic mesenchymal stem cells isolated from adipose tissue as the treatment for chronic wounds in diabetic foot syndrome in a double-blinded three armed setup.

Conditions

Diabetic Foot Ulcer

Keywords

adipose-derived mesenchymal stem cells; chronic wounds; diabetes; foot ulcer

Outcome Measures

Primary Outcomes (2)

• Change in wound size (%) at 6 weeks after first study treatment administration compared to baseline with the actual wound size measured by the independent assessor.

  Percentage change in wound size, measured by an independent assessor using a standardized wound area measurement method. The calculation is based on the difference between the baseline wound size and the wound size at 6 weeks, expressed as a percentage of the baseline value.

  6 weeks after the first administration

• Type, frequency and severity of adverse events (assessed according CTCAE v5.0); change from baseline of laboratory parameters and selected vital signs of the participants.

  Adverse events will be assessed based on type, frequency, and severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Changes from baseline in laboratory parameters and selected vital signs will be evaluated using standardized clinical measurement methods.

  6 weeks after the first administration

Secondary Outcomes (6)

• Early efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization)

  6 weeks after the first administration

• Long-term efficacy of the allogenic ADSC/ASC defined as percentage of patients with significant clinical success defined as complete wound closure (100% epithelialization), or partial epithelialization of the wound (>50% epithelialization) over time.

  Through study completion, an average of 1 year

• The dynamics of wound healing defined as the time required for patients to reach the wound size reduction thresholds: 50% reduction of the wound; maximum reduction of the wound area (%); complete wound healing .

  6 weeks after the first administration and through study completion, an average of 1 year

• Absolute change in the wound-associated pain perception over time assessed by the patient using visual analogue scale.

  6 weeks after the first administration and through study completion, an average of 1 year

• Additional safety parameters such as wound infection requiring antibiotic treatment expressed as total number of patients, and number of antibiotic therapies per patient.

  6 weeks after the first administration and through study completion, an average of 1 year .

Other Outcomes (1)

• Evaluation of the additional safety and efficacy parameters such as the percentage of patients requiring lower or upper limb amputation or the percentage of patients experiencing CVD events (CVD death, hospitalization for CVD reason)

  through study completion, an average of 1 year

Study Arms (3)

A - ADSC/ASC cells in fibrin solution - two times administration of ADSC/ASC

EXPERIMENTAL

Application of allogeneic ADSC stem cells in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard of care procedure for diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells in fibrin solution onto the wound surface.

Biological: A - Allogenic ADSC cells in fibrin solution - two times administration ADSC/ASC

B - ADSC/ASC cells in fibrin solution - one administration of ADSC/ASC, one administration placebo

EXPERIMENTAL

Application of allogeneic ADSC stem cells and placebo in fibrin gel, to cover wound surface with thin cells layer. Therapy is based on standard of care procedure for diabetic foot ulcer treatment combined with application of allogeneic ADSC stem cells and placebo in fibrin solution onto the wound surface.

Biological: B - Allogenic ADSC cells in fibrin solution - one time administration of ADSC/ASC, one time of placebo

C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

PLACEBO COMPARATOR

Standard of care procedure for diabetic foot ulcer with aplication of fibrin gel to cover wound surface. Application of fibrin gel to cover wound surface.

Other: C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

Interventions

A - Allogenic ADSC cells in fibrin solution - two times administration ADSC/ASC BIOLOGICAL

ADSC/ASC will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).

A - ADSC/ASC cells in fibrin solution - two times administration of ADSC/ASC

B - Allogenic ADSC cells in fibrin solution - one time administration of ADSC/ASC, one time of placebo BIOLOGICAL

ADSC/ASC will be administered once, at the time of the second application patients will receive a placebo - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed weekly, up to V6 visit (up to 6 weeks after V0)

B - ADSC/ASC cells in fibrin solution - one administration of ADSC/ASC, one administration placebo

C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface. OTHER

Placebo will be administered twice, at two-week intervals - during V0 and V2 visits The first dose will be administered one week after the randomisation visit. Control visits after administration will be performed every week, up to V6 visit (up to 6 weeks after V0).

C - Standard care in diabetic foot ulcer with aplication of fibrin gel to cover wound surface.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years at the time of consent,
• The patient's psychophysical and legal ability to give informed consent to participate in the study,
• Signing the informed consent document for participation in the study,
• Ulcer classified as diabetic foot syndrome (DFS) of neuropathic and/or neuroischemic etiology corresponding to grade IA/IIA and IC/IIC according to the University of Texas classification (Appendix E),
• Duration of the ulcer not less than 6 weeks,
• Presence of a wound with an area of 1-25 cm² (after wound debridement),
• Satisfactory blood supply to the wound area:
• assessed using transcutaneous oxygen pressure measurement, if its value is not less than 30 mmHg,
• or measurement of systolic blood pressure at the posterior tibial artery and/or dorsalis pedis artery, which is not less than 50 mmHg, to exclude patients who require revascularization therapy,
• Glycated hemoglobin (HbA1c) \< 11%,
• General health status of the patient, which in the investigator's opinion allows participation in all study procedures,
• Use of the wound offloading method recommended by the investigator,
• Use of effective contraception methods to avoid pregnancy (see also Appendix F) and/or based on the following criteria:
• a woman who is unable to have children (after a hysterectomy or bilateral oophorectomy or post-menopause, defined as a period of at least 12 months since the last menstrual period) is exempt from pregnancy tests,
• a woman able to have children with a negative pregnancy test result before the administration of the investigational product on the first day and who agrees to periodic pregnancy testing according to the study protocol and to use highly effective contraceptive methods for one month after the end of the active phase of the study (from V6), or two months after the last administration of the investigational drug (from V2).

You may not qualify if:

• Etiology of the ulcer other than diabetic foot syndrome,
• Wound area \<1 cm² or \>25 cm²,
• The patient was enrolled in another clinical trial within the 4 weeks preceding the qualification for this study.
• Clinically significant limb ischemia:
• assessed using transcutaneous oxygen pressure measurement, if its value is lower than 30 mmHg
• or measurement of systolic blood pressure at the posterior tibial artery and/or dorsalis pedis artery, if it is lower than 50 mmHg,
• Presence of an active phase of Charcot joint,
• Suspected osteitis and/or osteomyelitis within the study wound,
• Chronic kidney disease with GFR \< 20 ml/min,
• Pregnancy and lactation,
• Allergy to thrombin,
• Active venous thrombosis,
• Systemic diseases in the exacerbation stage (acute or decompensated), including heart, kidney, and liver diseases,
• Active alcohol disease or addiction to psychoactive substances,
• Allergies to dressing materials used in the study,

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical Research Agency, Poland: collaborator

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Foot Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Foot Diseases

Study Officials

• Beata Mrozikiewicz-Rakowska, Assoc.Prof.

  Bielanski Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beata Mrozikiewicz-Rakowska, Assoc.Prof.

CONTACT

+48 225690529; klinendo@bielanski.med.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be allocated to one of the following arms: Double administration of ADSC/ASC, single administration of ADSC/ASC or Placebo (control) all in addition to SOC treatment

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 24, 2025
• Study Start: March 8, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2024-11