A DOUBLE-BLIND, MULTI-CENTRIC, PLACEBO-CONTROLLED, STRATIFIED RANDOMIZED TRIAL TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF BOVINE BONE COLLAGEN PEPTIDE AS ADD-ON NUTRITIONAL SUPPLEMENT IN MANAGEMENT OF SUBJECTS WITH STAGE II AND STAGE III PRESSURE ULCER

itta Gelatin India Limited CochinIndia0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•Subjects of both sexes between 18 and 70 years of age with pressure ulcer.
•Subjects with BMI of 18.5 to 34.9.
•In patients and out patients
•Subjects who are diagnosed to have Stage II and Stage III pressure ulcers as adapted by the National Pressure Ulcer Advisory Panel (2007)1.
•Subjects with pressure ulcer surface area less than 80 sq.cm. (Measure the greatest length (head to toe) and greatest width (side to side) using a centimeter ruler).
•Subjects with stage II and III pressure ulcer with a PUSH score of 5 or more located anywhere on the body that is likely to heal over the 6 month study period.
•Subjects with moderate exudates amount.
•Subjects with normal CVS and RS function.
•Subjects with Braden score of 6 or more (Appendix -6).
•Attending physician considering the subject in general good health other than PU wound.
•Subjects, who are conscious, oriented and having ability to swallow food on his/her own.
•Subjects who have signed and dated written informed consent.
•Subjects who are willing to comply with the study procedure.

•Pregnancy, lactating women and women of child bearing potential not following adequate contraceptive measure.
•Subjects with stage IV pressure ulcer.
•Subjects on tube feedings.
•Subjects with diabetic foot ulcer.
•Subjects using immunotherapy, or cytotoxic chemotherapy within 60 days before enrollment. Systemic steroids 30 days prior to enrollment. Topical therapy other than steroidal upto 7 days prior to enrollment.
•Subjects who are HIV, HBV, HCV positive.
•Subjects with pre-existing or recent onset of demyelinating disorders.
•Subjects with hepatic, renal, or metabolic disease that is likely to interfere with the subjects participation in or completion of the study.
•Subjects with arterial or venous disorder resulting in ulcerated wounds.
•Subjects with history of established diabetes mellitus, with a fasting blood glucose level of more than 200 mg/dL.
•Subjects having any condition that would interfere with wound healing (e.g.: connective tissue disorder, immune disorder and clinical obesity).
•Subjects who are malnourished.
•Subjects having wounds due to malignancy.
•Subjects with burns or scalds.
•Subjects having wounds with active clinically diagnosed infection.
•Subjects who used Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months.

发起方

itta Gelatin India Limited CochinIndia