A RCT comparing the outcome of standard wound care and standard wound care combined with longitudinal distractive osteogenesis in chronic non-healing wounds of foot and ankle secondary to chronic limb ischemia

Abstract

Objective: To compare the outcome of standard wound care vs standard wound care with transverse distractive osteogenesis in chronic non-healing wounds of foot and ankle secondary to chronic limb ischemia. Design: A Prospective Randomized Controlled Trial Settings: Department of Orthopedics, Department of Surgery, Department of Emergency Medicine, BPKIHS, Dharan. Background: Many options are available for treatment of chronic wounds. The major hurdle for non-healing chronic wounds is the reduced vascular supply to the affected limb. This study tries to find out the true beneficial effect of transverse distractive osteogenesis which is proposed to increase vascularity and thus helping in healing of wounds. Methodology: 24 patients (From April 2017 – April 2018) were randomized to fall into two equal groups (12 each) for intervention. Group A wound receive standard wound care and Group B wound receive standard wound care combined with transverse distractive osteogenesis with Ilizarov apparatus. They were followed 3 months and assessed for various parameters for wound improvement. Results: There were total 24 patients (male n=13 and female n=11) with 12 in each group. There was no difference in age, gender, cause, timing of presentation between the two groups. Diabetic foot (75%, n=18) dominated the main cause. There was no statistical significance in Bates-Jensen wound Assessment score in initial 1 month of assessment. However, at 3 months, the mean BWAT score was 22.91 in distraction group vs 35.25 in standard wound care group; which was statistically significant (p=0.001). In the distraction groups, 2 patients had major complication of pin-tract infection and osteotomized part being sequestrum and had to be removed at 3 months. Definitive Wound closure was possible with split skin graft in 14 cases (37.5% vs 20%) and 2 reverse sural flaps (8.3%). All patients had positive culture result with monomicrobial status (74%) vs polymicrobial status (36%). No significant improvement in pain in patients with Burger’s disease was obtained. Conclusion: Distractive Angiogenesis greatly enhances the healing potential of wound secondary to chronic limb ischemia. However, the carries significant learning curve.