Cell Therapy for Diabetic Foot Ulcer
Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus, Wound Heal
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
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).
Sites / Locations
- Centro de Salud Familiar de Villa AlemanaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Advanced Healing
InbioDerm + C plus advanced healing
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
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.