A clinical study to evaluate the safety, tolerability and effectiveness of Soreze gel in existing Grade 1 pressure ulcers.

All the hospitalized patients falling under the inclusion criteria will be examined and those with grade 1 pressure ulcers (PU) and sign the informed consent will be recruited in the study. This will be a single arm open label study. The PUs prevention methods as per hospital protocol (e.g. daily evaluation of patient’s skin at a fixed timing, especially examination of pressure areas such as the sacrum, trochanter, heel, occipital area, shoulder, and changing. positions at least every 2 hours, using a small pillow between legs or heels to remove and reduce the pressure, urinary and fecal incontinence control, and using absorbent pads and cleaning the skin in case of contamination) will be done on a daily basis by nurses in the form of usual nursing care for all the patients and recorded. Soreze gel will be applied on the ulcerated or ulcer prone area. Before the removal of first dose, tube should be weighed and its weight to be recorded. The study doctor will observe the site for 2 hours for any local reactions like redness, a rash, or hives. The product is to be applied twice daily for 21 days (at 9 and 21 o’clock) on ulcerated areas as well as other ulcer prone areas and will be given 2–3 min to absorb. IP should be applied in a quantity just sufficient to form a thin film on affected area or PU prone area and little wider to cover the adjacent areas. While application of IP, apply the first layer of the product, allow to dry for a few seconds and then apply another thin layer on the area. This helps cover all the area very well. Please note only thin film is sufficient, ensure no affected areas should be left without film. In case of discharge from hospital before day 21, further follow up with the patient or care provider will be done telephonically. Patient or his care provider will be trained to record the necessary observations and patient diary will be maintained for IP compliance, PU prevention methods and recording relevant observations. If the day 21 visit gets delayed, patient must be asked to continue the application of IP till the day of last visit. IP application will be recorded and tube will be reweighed to record the weight after removal of last dose. Average weight of the product used can be calculated from the difference of final and initial tube weights. Ulcerated areas will be examined on days 0, 1, 3, 7, 14-and 21- days for safety parameters and reduction in ulceration