Health Condition 1: I873- Chronic venous hypertension (idiopathic)
Conditions
Interventions
Intervention1: DiperoxochloricAcid [DPOCL]topical solution brand named as WOXheal: This pack contains two bottles:
Bottle A: Diperoxochloric acidconcentrate (each ml of solution contains: Diperoxochlo
Sponsors
Centaur Pharmaceuticals Pvt. Ltd
CRO LifeSan Clinical Research division of Centaur Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age: > 18 to â?¤ 80 years. 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 or maximum 3 difficult-to-heal varicose or post-thrombotic venous leg ulcer on standard care (appropriate compression system) localized between the knee and ankle, including the perimalleolar area. 5.Venous insufficiency confirmed by a venous Doppler/ duplex ultrasound scan. A previous scan done within 6 months before randomization can be used. If there is no previous adequate scanning, a new scanning has to be performed before randomization. 6.The target ulcer area should be > 4cm2 and â?¤ 40 cm2 calculated by largest length Ã? largest width with less than 50% of necrotic tissue. 7.Ulcer duration â?¥2 months and â?¤3 years. 8.Target ulcer classification using WIFI grade: Wound 1 or 2, Ischemia 1 or 2, foot infection 1 or 2
Exclusion criteria
Exclusion criteria: 1.Patients with more than 3 ulcers in a single extremity. 2.Patients with ulcers measuring wound surface area more than 40 cm2 and deep ulcerations with bone or tendon exposure, or uncontrolled infection. 3.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. 4.Patients with severe limb ischemia. 5.Patients who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening. 6.Patients who have had a technically successful revascularization by surgery or angioplasty within 2 months. If Patients are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Patients who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure. 7.Treatment of foot ulcers with growth factors, stem cells or equivalent medication within the 8 weeks prior to screening. 8.Patients having progressive weight loss, i.e. â?¥ 20% within last 3 months prior to enrollment in the trial. 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 objective of this study is to evaluate the efficacy of Diperoxochloric acid topical solution in addition to standard of care causing complete wound closure or reduction in wound surface area in the chronic venous leg ulcers in comparison with active control 0.9% sodium chloride topical solution in addition to standard of care on the basis of primary, secondary and tertiary endpoints.Timepoint: Seven [7] visits are planned in this study: 1.Visit 0 will be the baseline on day 0 before first treatment by Test or Active-control medication, followed by 2.Visit 1: day 7, 3.Visit 2: day 14, 4.Visit 3: day 28, 5.Visit 4: day 42, 6.Visit 5: day 56 7.Visit 6: day 70 and 8.Visit 7: day 84 For each visit, a grace period of ± 3 days will be given to patients and will not be considered as protocol deviation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to evaluate the safety of Diperoxochloric acid topical solution in addition to standard of care in comparison with active control 0.9% sodium chloride topical solution in addition to standard of care by comparing treatment-emergent adverse events or serious adverse events as well as comparison of baseline and end-of-study assessment by virtue of physical examination and clinical laboratory investigationsTimepoint: Seven [7] visits are planned in this study: 1.Visit 0 will be the baseline on day 0 before first treatment by Test or Active-control medication, followed by 2.Visit 1: day 7, 3.Visit 2: day 14, 4.Visit 3: day 28, 5.Visit 4: day 42, 6.Visit 5: day 56 7.Visit 6: day 70 and 8.Visit 7: day 84 For each visit, a grace period of ± 3 days will be given to patients and will not be considered as protocol deviation. | — |
Countries
India
Contacts
Public ContactMr Rajendra M Sawant
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Outcome results
None listed