Non-healing diabetic foot ulcer. Non-insulin-dependent diabetes mellitus With peripheral circulatory complications. Diabetic ulcer
Conditions
Interventions
Intervention 1: cell graft plus dressing (cell suspension) applied once over the wound, but the dressing will be changed weekly to the time of wound healing or up to the 8 week. Intervention 2: Contro
cell graft plus dressing (cell suspension) applied once over the wound, but the dressing will be changed weekly to the time of wound healing or up to the 8 week
Control group receive dressing without cellular graft, and the dressing will be changed every 7 days up to the 8 week or the complete wound healing.
Sponsors
Isfahan University of Medical Sciences
Royan Research Center
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: both males and females, age 40-70 years old, with wounds area ranging from 2 to 6 cm2, (exposed bones may also be included if other criteria are filled), healing refractory despite comprehensive treatment for at least 6 weeks and Grade II, III and IV of Wagner's classification system (wound will be debrided), Wounds in the Gangrene stage are included if they are wet, but suppurative wounds may be enrolled after complete treatment of the infection. Mostly wounds with the cavity formation will be preferred to enrolled, as in the cases after debridement with a remained cavity unfilled with healed tissues, compliant, alert enough to understand the process of the research project which are high risk for amputation and are not indicated for vascular surgery or are unable to endure surgery are considered to be included. Exclusion criteria: Non-healing wounds with clinically or laboratory (ESR, CBC, CRP) diagnosed osteomyelitis, cellulitis or any kind of infection before infection control, Dry gangrene which makes no problem for the patient, patients with overt malignancy, chronic kidney disease over stage III, uncontrolled hyperglycemia (HbA1C> 9%) and other underlying disease other than DM (based on their files and caring physician information), other causes of non-inclusion are pregnancy, lactation, Poor hygiene, Consumption of special drugs with the effect on wound healing. patients with mental or psychological disorders and cases who are unable to understand or perceive the process of getting informed consent completely.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation.;Patient satisfaction scores. Timepoint: at 2-6-9-12 months. Method of measurement: patient satisfaction scores based on the VAS scoring system.;Occurrence of unexplained fever, weight loss. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: clinical observation.;Wound healing process. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation.;Local complications. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: clinical observation.;Clinical or laboratory abnormalities. Timepoint: 3, 6, 12 and 19th months. Method of measurement: lab data and clinical observation.;Wound healing time. Timepoint: every 7 days up to 8th week then bi-weekly up to 6 months. Method of measurement: Paper ruler, digital camera, lab data and clinical observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Need to amputation. Timepoint: 3, 6, 12 and 19th months. Method of measurement: Clinical observation, lab data.;Abnormal renal or hepatic function tests. Timepoint: 3, 6, 12 and 19th months. Method of measurement: lab data.;Mortality. Timepoint: from the begining of the study up to the 19th months. Method of measurement: Death occurrence. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohaddeseh Behjati
Isfahan University of Medical Sciences
Outcome results
None listed