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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05234086
Other study ID # INBIO EC 201903
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 2, 2020
Est. completion date September 2, 2022

Study information

Verified date February 2022
Source Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Contact Soledad Herrera
Phone 56966083093
Email soledadherrera@inbiocriotec.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2, 2022
Est. primary completion date May 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Chile Centro de Salud Familiar de Villa Alemana Villa Alemana Valparaíso

Sponsors (2)

Lead Sponsor Collaborator
Instituto para el Desarrollo Biotecnológico y la Innovación S.A. Corporación de Fomento de la Producción, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with completely closed ulcers The principal investigation and external evaluator will assess every fifteen days the wound closure status. 16 weeks
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