diabetic foot ulcer. Diabetes mellitus due to underlying condition with foot ulcer
Conditions
Interventions
Intervention 1: Intervention group: Silicone dressing (monlyke company) and ADM (Iranian tissue product company) with allogenic adipose-derived stromal cells, 1 million cells/cm2 of wound, every 2 wee
Sponsors
???? ??????? ???? ? ???? ??? ?????? ??????? ???? ????? ?????
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age 18 -60 Type 1 or Type 2 diabetes Able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Ulcer size 2-20 cm2 Ulcer duration of more than 4 weeks, unresponsive to standard wound care No clinical signs of infection Serum creatinine <3 mg/dl HbA1c <12% ABI between 0·7 and 1·2
Exclusion criteria
Exclusion criteria: wound duration of >52 weeks without intermittent healing Index ulcer probing to tendon, muscle, capsule or bone Currently receiving radiation or chemotherapy Known or suspected malignancy of current ulcer Diagnosis of autoimmune connective tissue disease Use of biomedical/topical growth factor within previous 30 days Pregnant or breast feeding Taking medications considered to be immune system modulators Allergy or known sensitivity to Gentamicin, Streptomycin or bovine collagen Wounds improving more than 20% over the 4-week run-in period of the trial using standard of care. Patient taking Cox-2 inhibitors. HBV, HCV or HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound extent (cm2). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: Image J software. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety. Timepoint: intervention start date up to 6 months. Method of measurement: Medical history and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Bajouri
Tehran University of Medical Sciences
Outcome results
None listed