Authors
»
[No authors listed]
Category
»
Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
»
2010
INTERVENTION: 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. 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: 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. CONDITION: Non‐healing diabetic foot ulcer. ; Non‐insulin‐dependent diabetes mellitus With peripheral circulatory complications. Diabetic ulcer Non‐insulin‐dependent diabetes mellitus With peripheral circulatory complications. Diabetic ulcer PRIMARY OUTCOME: Clinical or laboratory abnormalities. Timepoint: 3, 6, 12 and 19th months. Method of measurement: 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. 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. Patient satisfaction scores. Timepoint: at 2‐6‐9‐12 months. Method of measurement: patient satisfaction scores based on the VAS scoring system. 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. 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. 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 OUTCOME: 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. Need to amputation. Timepoint: 3, 6, 12 and 19th months. Method of measurement: Clinical observation, lab data. Exclusion criteria: Non‐healing wounds with clinically or laboratory (ESR, CBC, CRP) diagnosed osteomyelitis, cellulitis or any ki 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.
Epistemonikos ID: 8b7228f04e8a51328e62b708e3c41c5e1bdbffb6
First added on: Aug 22, 2024