Wagner ulcer grade II. Diabetes mellitus
Conditions
Interventions
Intervention 1: In intervention group, the bilayer scaffold is used as a wound dressing and is changed once a week over a 6-weeks period. The bilayer scaffold is based on amniotic membrane and silk fi
Treatment - Other
In intervention group, the bilayer scaffold is used as a wound dressing and is changed once a week over a 6-weeks period. The bilayer scaffold is based on amniotic membrane and silk fibroin and is fab
In control group, decellularized amniotic membrane is used as a wound dressing and is changed once a week over a 6-weeks period.
Sponsors
Deputy of Research and Technology of Avicenna Research Institute
Center for Research and Training in Skin Diseases and Leprosy
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: diagnosed with diabetes; within the age range of 18 to 60 years; wound area between 1 to 20 square centimeter; one month passed wound creation Exclusion criteria: simultaneous wound infection (active cellulite, osteomyelitis, sinus infection, etc.); more than 50% wound healing in one month period prior to intervention; simultaneous diagnosis with metastatic diseases or malignant diseases, especially those involving hematologic system or bone; receiving chemotherapy or immunosuppressive medications; simultaneous diagnosis with an autoimmune disease such as chronic lymphocytic thyroiditis, arthritis rheumatoid, and lupus; administration of therapeutic agents containing growth factors; hemoglobin level of less than 10 mg/dl or thrombocytopenia (platelets of less than 100,000); serum albumin level of less than 2.5 g/dl; records of vascular surgery in 3 months period prior to intervention; addiction to oral or injectable narcotic drugs; diagnosis with any systemic disease which would interfere with the process of wound healing; pregnancy, breastfeeding; history of vascular disorders or neuropathy; history of diagnosis with hematologic disorders; diagnosis with any conditions requiring treatment such as gangrene; application of injectable, oral antibiotic in 48 hours prior to intervention; patient participation in other clinical trials in three months pre-intervention; no disruption in blood circulation to the wounded region
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound dimension. Timepoint: Before intervention and after intervention on days 7, 14, 30, 45 and 60. Method of measurement: Caliper.;Wound colour. Timepoint: Before intervention and after intervention on days 7, 14, 30, 45 and 60. Method of measurement: Dermaspectrometer, chromameter and observer.;Biomechanical properties. Timepoint: After intervention on days 7, 14, 30, 45 and 60. Method of measurement: Tensile testing.;Wound surface properties. Timepoint: After intervention on days 7, 14, 30, 45 and 60. Method of measurement: Three-dimensional optical profiling system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tissue healing. Timepoint: Sixty days after intervention. Method of measurement: Hematoxylin and eosin staining.;Quality assessment of involucrin. Timepoint: Sixty days after intervention. Method of measurement: Involucrin immunohistochemical staining.;Tissue reconstruction. Timepoint: Sixty days after intervention. Method of measurement: Masson's trichrome staining.;Quality assessment of collagen. Timepoint: Sixty days after intervention. Method of measurement: Collagen immunohistochemical staining.;Quality assessment of p63. Timepoint: Sixty days after intervention. Method of measurement: P63 immunohistochemical staining. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Alireza Firooz
Center for Research and Training in Skin Diseases and Leprosy
Outcome results
None listed