Cell Therapy for Diabetic Foot Ulcer

NCT ID: NCT05234086

Last Updated: 2022-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2022-09-02

Brief Summary

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.

Conditions

Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Advanced Healing

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

Group Type: ACTIVE_COMPARATOR

Advanced healing

Intervention Type: PROCEDURE

Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.

InbioDerm + C plus advanced healing

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.

Group Type: EXPERIMENTAL

InbioDerm + C plus advanced healing

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

InbioDerm + C plus advanced healing

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.

Intervention Type: COMBINATION_PRODUCT

Advanced healing

Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corporación de Fomento de la Producción, Chile

UNKNOWN

Sponsor Role: collaborator

Instituto para el Desarrollo Biotecnológico y la Innovación S.A.

OTHER

Sponsor Role: lead

Responsible Party

Soledad Herrera

Regulatory Affairs - Inbiocriotec

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Franco Ahumada

Role: PRINCIPAL_INVESTIGATOR

Centro de Salud Familiar Villa Alemana

Locations

Centro de Salud Familiar de Villa Alemana

Villa Alemana, Región de Valparaíso, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Soledad Herrera

Role: CONTACT

soledadherrera@inbiocriotec.cl

56966083093

Caroline Weinstein-Oppenheimer

Role: CONTACT

caroline.weinstein@uv.cl

56322508140

Facility Contacts

Franco Ahumada, MD

Role: primary

franco.ahumada@gmail.com

56965487096

Other Identifiers

INBIO EC 201903

Identifier Type: -

Identifier Source: org_study_id