Diabetic wound. Diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention: Prepared scaffold with keratinocyte, fibroblast and SVF cells processed from autologous fat and skin, respectively, are applied in the diabetic wounds and would healing w
Treatment - Surgery
Intervention: Prepared scaffold with keratinocyte, fibroblast and SVF cells processed from autologous fat and skin, respectively, are applied in the diabetic wounds and would healing would be monitore
Control: Prepared scaffold without cells in control group is applied in the diabetic wounds.
Sponsors
Vice Chancellor for research of Kashan University of Medical Sciences,
Vice Chancellor for research of Skin and Stem Cell Research Center,
Eligibility
Sex/Gender
Male
Age
15 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criterion:diabetic patients with less than 2 square millimeters wounds involvement. Exclusion criteria:(Actively) infected ulcer; Immune deficient patients; Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment; Patients receiving systemic or injection of antiangiogenic drugs; Patients with poorly controlled diabetes mellitus.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascularization in culture media (in Vitro). Timepoint: Three weeks after transplantation. Method of measurement: Number of gap junction and pinocytotic vesicles of counted by transmission electron microscopy analyses.;Sebometer. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;PHmeter. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;Pigmentation. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;Colorimeter. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;Skin Hydration. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;Cutometer. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Biometry.;Wound size. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Count the squares (in centimeters) after placing the acetate sheet over a wound,measurements the size of the wound using a ruler.;Graft take. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Clinical judgment.;Vascularization in In Vivo. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Clinical judgment.;Percentage of mature endothelial cells. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Flowcytometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound infection. Timepoint: Fourth, 7th and 14th days after transplantation. Method of measurement: Appearance of wound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahsa Mollapour
Skin and Stemcell Research center, Tehran University of Medical Sciences
Outcome results
None listed