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

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, Multi-centered, Non-Randomized, Non-Comparative Active Post-Marketing Surveillance 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 at 20 centers, with number of patients not less than 200 and not more than 500.

Total duration of the clinical trial will be of 70 days. At day 0, patient/ patients guardian will be informed about the ‘’Active 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.

On visits 0 and 1, one investigational product will be provided to the subject whereas on visits 2, 3, 4 and 5 two investigational products will be provided to the subject by the investigator at no cost.

All the patients will be asked to revisit the clinical trial center for efficacy and safety assessment 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 cm 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.