Status:
UNKNOWN
Cell Therapy for Diabetic Foot Ulcer
Lead Sponsor:
Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Collaborating Sponsors:
Corporación de Fomento de la Producción, Chile
Conditions:
Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05234086
Start Date
January 2 2020
End Date
September 2 2022
Last Update
February 10 2022
Active Locations (1)
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1
Centro de Salud Familiar de Villa Alemana
Villa Alemana, Región de Valparaíso, Chile, 2550880