A Prospective, Open-Label, Non-Randomized, Non-Comparative Observational post marking surveillance study 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 Ltd1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2025年10月27日最近更新: 2025年10月14日

试验速览

阶段: Unknown
状态: 尚未招募
发起方: Centaur Pharmaceuticals Pvt Ltd
入组人数: 30
试验地点: 1
主要终点: 1.Percentage of patients achieving Complete Wound Closure (CWC).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Diperoxochloric Acid Topical solution is indicated for wound healing in diabetic neuropathy ulcer of skin and subcutaneous tissue.

Overview of the Study Design

It will be a Prospective, Open-Label, Non-Randomized, Non- Comparative, Observational Post-Marketing Surveillance study to test the safety and efficacy of Diperoxochloric Acid [DPOCL] topical solution in patients with diabetic neuropathic ulcers of skin and subcutaneous tissue. The study will be conducted on 30 patients. The total duration of the clinical trial will be of 70 days. At day 0, patient/ patients guardian will be informed about the ‘’Observational Post-Marketing Surveillance’’. If the patient agrees and eligible as per inclusion and exclusion criteria, then his/ her sign will be taken on ICF and patient will be recruited. All the patients will be asked to revisit the clinical trial center for efficacy and safety assssment at day 7, day 14, day 28, day 42, day 56 and day 70 along with their lab reports of day 0 and day 70. For each visit, a grace period of ± 2 days will be given to patients and will not be considered as protocol deviation.

Study Objective(S):

Primary Objective

The primary objective of this study is to evaluate the safety of Diperoxochloric Acid [DPOCL] topical solution in patients with diabetic neuropathic ulcers of skin and subcutaneous tissue on the basis of AE/ SAE, clinical chemistry (safety lab) and complete physical examination.

Secondary Objective

The secondary objective of this study is to evaluate the efficacy of Diperoxochloric Acid [DPOCL] topical solution in patients with diabetic neuropathic ulcers of skin and subcutaneous tissue.

Dosage:

Before applying to the wound dressing, Diperoxochloric Acid concentrate (Bottle A) has to be ‘’reconstituted’’ by mixing the contents of bottle A into the contents of bottle B as per the instructions provided below.

Instructions for preparation of Diperoxochloric Acid Topical Solution “Reconstituted’’ solution and wound dressing.

· Open ‘Bottle A’ and ‘Bottle B’.

· Pour the contents of Bottle A into Bottle B.

· Close the bottle B with bottle cap.

· Discard the bottle A.

· Mix the content by moving the bottle upside down for 5 times gently.

Application

· Wash hands thoroughly before applying DPOCL topical solution.

· Take out the dropper from the plastic bag (provided in the pack) and fill it on the bottle B.

· Apply 3.5 mL of this solution with help of the dropper on the 5 x 5 m dressing (inner gauze) to bring the dressing to earth moist conditions.

· Do not touch dropper to the dressing or gauze.

· Then apply this inner gauze on the wound.

· Cover this inner gauze with outer gauze which will prevent the wound area from running dry.

· Fix the gauze in position by rolling the bandage over the gauze and secure the ends by the microtape.

· Daily remove the outer bandage and apply investigational product on inner bandage without removing the inner bandage form the wound.

· Change the outer gauze daily and inner gauze on every alternate day

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•Patients diagnosed with either Type I or II diabetes mellitus.
•Patients having random blood sugar [RBG] of Less than 250 mg/dL on standard anti-diabetic treatment 3)Patients having glycosylated hemoglobin of less than 12%.
•Age: more than 18 years of either gender (Male/ Female).
•Ulcers with wound surface area measured by greatest length, greatest width between 1 cm2 and 25 cm2 post debridement on the day
•At least 1 but not more than 3 full thickness [i.e. extending into subcutaneous tissue or beyond] ulcer at foot or below malleolus with at least 4 weeks history and graded as stage I A, II A or I B on University of Texas wound classification system 7) Patients with Ankle-Brachial Pressure Index [ABPI] more than 0.7 8) All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form.

排除标准

•Patients with more than 3 ulcers.
•Patients with ulcers measuring wound surface area more than 25 cm
•Ulcers caused by venous or arterial insufficiency or electrical or chemical burns.
•Ulcers caused by surgery and especially amputation surgery.
•Ulcers showing presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
•Patients having history of active Charcoat’s foot of the study foot within 6 months of screening.
•Patients having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
•Patients having glycosylated hemoglobin of more than 12%.
•Patients having progressive weight loss.
•Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.
•Other diseases, which can alter the course of diabetic foot ulcer such as connective tissue disease, renal failure (serum creatinine more than 3mg /dL) liver failure, malignancy.
•Revascularization surgery performed less than 8 weeks before entry in the study.
•Pregnant or nursing mothers.
•Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
•Patients with Ankle-Brachial Pressure Index [ABPI] less than 0.7.