To evaluate new cellular therapy for non-healing diabetic foot ulcer

Phase 1

• Conditions: on-healing diabetic foot ulcer.; Non-insulin-dependent diabetes mellitus With peripheral circulatory complications. Diabetic ulcer

• Registration Number: IRCT138812133487N1
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

Int Wound J. 2013 Apr 2. doi: 10.1111/iwj.12043. [Epub ahead of print]<br /> <br /> Safety, efficacy and pitfalls of fibrocyte application in the treatment of diabetic foot ulcer.<br /> <br /> Behjati M, Hashemi M, Shoarayenejati A, Karbalaie K, Nasr-Esfahani MH.<br /> <br /> <br /> Source<br /> <br /> Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.<br /> <br /> <br /> Abstract<br /> <br /> <br /> Fibrocytes are unique bone marrow-derived cells with great potential in wound healing. Hence, the aim of this study was to determine the safety and efficacy of the applied circulating fibrocytes in the treatment of non healing diabetic foot ulcers. Peripheral blood mononuclear cells were isolated by centrifugation through Ficoll-Paque method. After 3?days, the non adherent cells were removed by a single, gentle aspiration. Adherent cells were cultured in the same medium for 10?days. The cells were characterised using mouse anti-human-CD45-fluorescein isothiocyanate (FITC) and mouse anti-human-collagen I, and also characterised by immunofluorescence microscopy using the above mentioned antibodies. Sterility measures were applied for clinical evaluation. Based on the literature review, cell transplantation generally requires at least 3?×?106 cells regarding efficacy measures. As fibrocytes are non proliferating cells, 350?ml patient's blood is required to prepare patient-specific serum before cell isolation and culture, and 85?ml patient's blood is needed for cell isolation and differentiation on cell transplantation applications. In our survey, no diabetic patient was inclined to be donor of such blood volume, mainly because of their pre-assumption that they are anaemic. It is concluded that fibrocytes do not seem to be<br />

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified