Clinical trial NCT05234086: Cell Therapy for Diabetic Foot Ulcer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Wound Heal
Lead sponsor: Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Sponsor class: OTHER
Collaborators: name: Corporación de Fomento de la Producción, Chile
First posted: 2022-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Proportion of patients with completely closed ulcers
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Villa Alemana
country: Chile
facility: Centro de Salud Familiar de Villa Alemana
state: Valparaíso
Study officials:
affiliation: Centro de Salud Familiar Villa Alemana
name: Franco Ahumada
role: PRINCIPAL_INVESTIGATOR
References: