Cell Therapy for Diabetic Foot Ulcer

Study Overview
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Brief Summary
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Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered. Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes. The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.

Official Title
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Randomized, Controlled Phase II Clinical Study to Evaluate Superiority of InbioDerm+C Autologous Stem Cell-Based Therapy Plus Advanced Healing Compared With Advanced Healing in Diabetic Foot Ulcer Patients

Conditions
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Wound Heal, Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Intervention / Treatment
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* Combination Product: InbioDerm + C plus advanced healing
* Procedure: Advanced healing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 18 years old and under 75 years old. Patient diagnosed with DM type II. Patient with negative pregnancy test. Ulcer size with area between 1 cm2 and 12 cm2. Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement. Ulcer age ≥ at one month. Patients with palpable posterior tibial and pedial pulse Exclusion Criteria: Patients with non-diabetic ulcers. Toe ulcers. Patient with grade IV and V renal insufficiency. Pregnant or breastfeeding women, or those who are planning to conceive children. Clinical evidence of infection. Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse) History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols) Allergy to penicillin, streptomycin, and gentamicin Subjects undergoing treatment with immunosuppressants and corticoids. Subjects on anticoagulant treatment with acenocoumarol and warfarin. Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advanced Healing<br>Activities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer | Procedure: Advanced healing<br>* Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.<br>|
| Experimental: InbioDerm + C plus advanced healing<br>For patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program. | Combination Product: InbioDerm + C plus advanced healing<br>* For patients who are assigned to experimental treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section, through an enzymatic process and cell proliferation for a period of approximately fourteen days, the cells that are integrated in the InbioDerm+C will be obtained and used to treat the foot ulcer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with completely closed ulcers | The principal investigation and external evaluator will assess every fifteen days the wound closure status. | 16 weeks |