Safety and efficacy of Diperoxochloric acid topical solution among people with diabetic neuropathic ulcer

Phase 4

• Conditions: Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications

• Registration Number: CTRI/2021/09/036483
• Lead Sponsor: Centaur Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

screening

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified