Active Post-Marketing Surveillance of Diperoxochloric Acid [DPOCL] in patients with diabetic neuropathic ulcers of skin and subcutaneous tissue

Recruitment & Eligibility

Status: Open to Recruitment

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 7%.

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 [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.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 Charcoat’s foot of the study foot within 6 months of screening.

7.Subjects having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG > 250 mg/dL).

8.Subjects having glycosylated hemoglobin of more than 12%.

9.Subjects having progressive weight loss.

10.Treatment with corticosteroids, immunosuppressive or chemotherapeutic agents, radiotherapy.

11.Other diseases, which can alter the course of diabetic foot ulcer such as connective tissue disease, renal failure (serum creatinine > 3mg /dL) liver failure, malignancy.

12.Revascularization surgery performed <8 weeks before entry in the study.

13.Pregnant or nursing mothers.

14.Mentally or neurologically disabled subjects that are considered not fit to approve their participation in the study.

15.Subjects with Ankle-Brachial Pressure Index [ABPI] < 0.7.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.Timepoint: at every visit that is week 1, week 2, week 3, week 4, week 6, week 8 and week 10

Secondary Outcome Measures

Name	Time	Method
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.Timepoint: at every visit that is week 1, week 2, week 3, week 4, week 6, week 8 and week 10