Cell Therapy for Diabetic Foot Ulcer

NCT05234086 | Unknown Phase 2

• 1 other identifier: INBIO EC 201903
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with completely closed ulcers

  The principal investigation and external evaluator will assess every fifteen days the wound closure status.

  16 weeks

Study Arms (2)

Advanced Healing

ACTIVE COMPARATOR

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

InbioDerm + C plus advanced healing

EXPERIMENTAL

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

Interventions

InbioDerm + C plus advanced healing 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.

InbioDerm + C plus advanced healing

Advanced healing PROCEDURE

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

Advanced Healing

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Instituto para el Desarrollo Biotecnológico y la Innovación S.A.: lead
• Corporación de Fomento de la Producción, Chile: collaborator

Study Sites (1)

Centro de Salud Familiar de Villa Alemana

Villa Alemana, Región de Valparaíso, 2550880, Chile

RECRUITING

Study Officials

• Franco Ahumada

  Centro de Salud Familiar Villa Alemana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soledad Herrera

CONTACT

56966083093; soledadherrera@inbiocriotec.cl

Caroline Weinstein-Oppenheimer

CONTACT

56322508140; caroline.weinstein@uv.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will evaluate encrypted images and tables containing healing valoration data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regulatory Affairs - Inbiocriotec

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: January 2, 2020
• Primary Completion: May 1, 2022
• Study Completion: September 2, 2022
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)