Health Condition 1: L899- Pressure ulcer of unspecified site
Conditions
Interventions
Intervention1: Diperoxochloric Acid [DPOCL] topical solution brand named as WOXheal: This pack contains two bottles: Bottle A: Diperoxochloric acid concentrate (each ml of solution contains: Diperoxoc
Sponsors
Centaur Pharmaceuticals Pvt. Ltd
CRO LifeSan Clinical Research division of Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: > 18 to 2. Gender: Male or female 3. All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form. 4. Patients with at least one pressure ulcer belonging to stage II and III according to the US National Pressure Ulcer Advisory Panel (NPUAP). [Note: In case the Subject has more than one pressure ulcers, only the largest diameter ulcer will be assessed.] 5. The maximum wound surface area is
Exclusion criteria
Exclusion criteria: 1. Patients with ulcers measuring wound surface area more than 50 cm2 and deep ulcerations with bone or tendon exposure, or uncontrolled infection. 2. Patients with pressure ulcer classified other than stage II and III according to NPUAP staging system. 3. Patients with history of allergy to materials in the study dressings. 4. Patients having ulcers from other etiologies (tumor, infection, amputation, dehisced surgical, venous, ischaemic, traumatic or diabetic foot ulcer) 5. Patients who have excessive tissue necrosis that is unlikely to benefit from medication, or those Patients who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening. 6. Ulcers treated with negative pressure wound therapy within last 3 months prior to enrolment in the trial. 7. Patients having progressive weight loss, i.e. >= 20% within last 3 months prior to enrollment in the trial. 8. Patient with active neoplastic lesion treated with radiation or chemotherapy. 9. Poor nutritional status albumin 10. Treatment with corticosteroids, immunosuppressive or chemotherapeutic/ cytotoxic agents, radiotherapy â?? either ongoing or within 60 days prior to enrolment in the trial. 11. Other diseases, which can alter the course of ulcer such as connective tissue disease, renal failure (serum creatinine > 3mg /dL) liver failure, malignancy. 12. Pregnant or nursing mothers. 13. Mentally or neurologically disabled Patients that are considered not fit to approve their participation in the study. 14. Participation in another experimental clinical study during previous 3 months prior to entry in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary outcome of this trial is - 1.Comparison between treatment groups: Percentage of patients achieving Complete Wound Closure (CWC) or complete healing. 2. Comparison between treatment groups: Assessment of wound healing as per PUSH score â?? change between PUSH score at visit 1 and at EOT. 3.Comparison between treatment groups: Time to achieve CWCTimepoint: Baseline visit i.e. Visit 1- Day 0, Visit where complete wound closure is achieved [Visit 2 to Visit 6] and Last Visit i.e. Visit 07 day 06. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between treatment groups that is Relative assessment of wound healing as per PUSH score & Relative wound area reduction & Wound area reduction & Improvement of subjective symptoms & Improvement of objective clinical symptoms & Quality of life.Timepoint: Visit 1 day 0 & EOT Visit 7 Day 56 | — |
Countries
India
Contacts
Public ContactDr Mukund Zarapkar
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Outcome results
None listed