To compare the efficacy of amniotic membrane as the biological dressing versus conventional saline dressing in management of lower limb diabetes related foot ulcer.

Lower limb Diabetes-related foot ulcer (DFU) is a major complication of diabetes causing significant morbidity and mortality all over the world. Depending on the nature and extent of the wound, the healing process may take up to 6 to 12 months or sometimes even longer.  The treatment of DFU remains complex, with the primary aim being offloading (pressure relief), with the Total contact casting (TCC), orthosis or using modified footwear.  In our department, the standard of care is TCC and the use of Bohler iron in clean ulcers which allows the mobility of the patient with total offloading.   A new method of treatment for DFU that we propose is the use of amniotic membrane as a biological dressing .  Patients with chronic diabetic foot ulcer attending the PMR OPD and integrated diabetic foot clinic will be recruited for the study. Patients who consent for the study will be randomized using Computer generated randomization to allocate each patient into control group and interventional group. Both the groups will be given the current standard casting with bohler iron with Total contact casting as the complete offloading technique.  Casting with bohler iron will be done in both the groups on day 1,11, and day21 .  A window will be made at the site of the DFU site for both the groups and regular saline dressing will be done daily for the control arm. For the intervention arm, Placenta will be procured from the labor room in CMC hospital and the amniotic membrane will be separated and prepared. This biological dressing will be applied on the ulcers of the participants recruited in the interventional arm at day 1,11 and day 21 of the study. A sterile op-site over the bohler iron will be applied over the cast of the participants in the interventional group after the application of amniotic membrane in order to prevent infection while travel to their homes/lodge. Two photographs of the DFU will be taken for both the groups, first on day 1 prior to casting, third during post cast removal on day 30. All photograph will be analyzed by the image software CATER  (Center for Advanced Technology Enabled rehabilitation) created by the Department of PMR and the accurate size and the area of the ulcers of the control and interventional group will be compared. Appropriate descriptive and analytical statistics will be done to establish the study objectives.