A Prospective, Open-Label, Multi-centered, Non Randomized, Non-Comparative Active Post-Marketing Surveillance to test the safety and efficacy of Diperoxochloric Acid [DPOCL]topical solution in Subjects with diabetic neuropathic ulcers of skin and subcutaneous tissue

Centaur Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Subjects diagnosed with either Type I or II - diabetes mellitus
•2. Subjects having random blood sugar [RBG] of < 250 mg/dL on standard anti-diabetic treatment
•3. Subjects having glycosylated hemoglobin of less than 12%
•4. Age: >18 years of either gender (Male/ Female)
•5. Ulcers with wound surface area measured by greatest length, greatest width between 1
•cm2 and 25 cm2 post-debridement on the day 0
•6. At least 1 but not more than 3 full thickness
•7. Subjects with Ankle-Brachial Pressure Index [ABPI] > 0.7
•8. All the subjects willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form

•1. Subjects with more than 3 ulcers
•2. Subjects with ulcers measuring wound surface area more than 25 cm2
•3. Ulcers caused by venous or arterial insufficiency or electrical or chemical burns
•4. Ulcers caused by surgery and especially amputation surgery
•5. Ulcers showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement
•6. Subjects having history of active Charcotâ??s foot of the study foot within 6 months of
•7. Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents,
•radiotherapy
•8. Revascularization surgery performed <8 weeks before entry in the study
•9. Pregnant or nursing mothers
•10. Mentally or neurologically disabled subjects that are considered not fit to approve their participation in the study
•11. Subjects with Ankle-Brachial Pressure Index [ABPI] < 0.7

发起方