NCT05234086

Cell Therapy for Diabetic Foot Ulcer

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Instituto para el Desarrollo Biotecnológico y la Innovación S.A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
PROCEDURE	Advanced healing	Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.

Timeline

• Start date: 2020-01-02
• Primary completion: 2022-05-01
• Completion: 2022-09-02
• First posted: 2022-02-10
• Last updated: 2022-02-10

Locations

1 site across 1 country: Chile