CTRI/2023/06/054253 [Registered on: 21/06/2023] Trial Registered Prospectively
Last Modified On:
08/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Other (Specify) [Topical Solution]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Phase III Clinical trial of WOXheal® Diperoxochloric Acid [DPOCL] in the treatment of chronic venous leg ulcers
Scientific Title of Study
A multicenter, randomized, double-blind, active-control phase III clinical trial of WOXheal® [Diperoxochloric acid] topical solution in the treatment of chronic venous leg ulcer – in comparison with the active-control 0.9% sodium chloride topical solution in addition to standard of care.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
LCT-01/21, version no. 3.0, dated 20-Oct-2022
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mukund Zarapkar
Designation
Vice President- Clinical
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400055 India
Phone
91-22-66499154
Fax
Email
drzarapkar@lifesan.in
Details of Contact Person Scientific Query
Name
Dr Mukund Zarapkar
Designation
Vice President- Clinical
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
MAHARASHTRA 400055 India
Phone
91-22-66499154
Fax
Email
drzarapkar@lifesan.in
Details of Contact Person Public Query
Name
Mr Rajendra M Sawant
Designation
Executive-Clinical Trial
Affiliation
LifeSan Clinical Research, division of Centaur Pharmaceuticals Pvt.Ltd.
Address
5th and 6th floor, B-wing, Centaur House, Near Hotel Grand Hyatt, Santacruz East, Mumbai 400055, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400055 India
Phone
91-22-66499243
Fax
Email
rajendras@lifesan.in
Source of Monetary or Material Support
Sponsor of the study i.e. Centaur Pharmaceuticals Pvt. Ltd. Contact details:912266499100
Primary Sponsor
Name
Centaur Pharmaceuticals Pvt. Ltd
Address
Centaur House, Opp. Grand Hyatt, Vakola, Santacruz – East, Mumbai - 400 055, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
CRO LifeSan Clinical Research division of Centaur Pharmaceuticals Pvt Ltd
5th and 6th floor, B wing, Centaur House, Opp. Grand Hyatt, Vakola, Santacruz – East, Mumbai - 400 055, India.
Pack contains two bottles:
Bottle A: Sterile Sodium Chloride Solution BP 0.9% w/v (Cutaneous Solution)
Bottle B: Sterile Sodium Chloride Solution BP 0.9% w/v (Cutaneous Solution)
Composition:
Sodium Chloride IP- 0.9% w/v in sterile neutralized aqueous vehicle - q.s.
Intervention
DiperoxochloricAcid [DPOCL]topical solution brand named as WOXheal
This pack contains two bottles:
Bottle A: Diperoxochloric acidconcentrate (each ml of solution contains: Diperoxochloric AcidConcentrate - 1.16 mg) Bottle B: Sterile Sodium ChlorideSolution BP - 0.9% w/v Prior to application bottle A will be mixedwith bottle B and Reconstituted Solution (Bottle A + Bottle B)would be prepared in the bottle B.
The dosage of reconstituted solution is 3.5 mL which is apply with help of the dropper on the 5 x 5 cm dressing (inner gauze) to bring the dressing to earth moist conditions. As per size of the dressing, the dose would vary, i.e. for 5 x 10 cm dressing (inner gauze), 7 mL solution would be needed, whereas for 10 x 10 cm dressing (inner gauze), 14 mL solution would be needed. Similarly, for 4 x 4 cm dressing (inner gauze), 2.5 mL solution would be needed.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1.Age: > 18 to ≤ 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 ≤ 40 cm2 calculated by largest length × largest width with less than 50% of necrotic tissue.
7.Ulcer duration ≥2 months and ≤3 years.
8.Target ulcer classification using WIFI grade: Wound 1 or 2, Ischemia 1 or 2, foot infection 1 or 2
ExclusionCriteria
Details
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. ≥ 20% within last 3 months prior to enrollment in the trial.
9.Poor nutritional status albumin < 2.5 g/dL or total protein < 4.5 g/dL.
10.Treatment with corticosteroids, immunosuppressive or chemotherapeutic/ cytotoxic agents, radiotherapy – 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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
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.
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 Outcome
Outcome
TimePoints
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 investigations
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.
Target Sample Size
Total Sample Size="204" Sample Size from India="204" Final Enrollment numbers achieved (Total)= "229" Final Enrollment numbers achieved (India)="229"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Diperoxochloric acid topical solution is
approved by CDSCO in the indication of diabetic neuropathic foot ulcer of skin
and subcutaneous tissue. From the data available from phase II and phase III clinical
trial, DPOCL caused faster healing of the ulcer when compared to active-control
treatment in terms of week wise percentage reduction in wound surface area. It
was also observed that certain clinicians successfully used WOXheal
[Diperoxochloric acid] topical solution off-label in the treatment of
non-healing venous leg ulcers, decubitus ulcers [pressure ulcers] as well as
other non-healing ulcers caused by collagen vascular disease.Therefore, this clinical trial is planned to
investigate efficacy and safety of WOXheal [Diperoxochloric acid] topical
solutionin the treatment of
venous leg ulcers in addition to standard care of treatment.
Study design:
1. Diperoxochloric
acid topical solution is approved by CDSCO in the indication of diabetic neuropathic
foot ulcer of skin and subcutaneous tissue7. This clinical trial is
planned as part of approval of Diperoxochloric acid topical solution in the
additional indication of chronic venous leg ulcers based on this new phase III
randomized clinical trial in compliance with New Drug and CT rules, March 19,
2019 [GSR 227E].
2. It
will be a prospective, double-blind, multi-centered, randomized, active-control,
comparative phase III clinical trial to test the efficacy and safety of
Diperoxochloric Acid [DPOCL] topical solution in patients with chronic venous
leg ulcers in addition to standard of care vis-Ã -vis isotonic normal saline
solution.
3.The
study will be conducted in the hospital setup, with number of patients not less
than 204, i.e. at least 102 in the Test arm and 102 in the Active-control arm
for a statistically evaluable 84 patients in each arm. The patients could be
treated on outpatient [OP] basis or may be in need of in-patient admission
[IP]. The sample size estimation is described in section 17.1 of this protocol.
4.A
detailed medical history will be obtained from all enrolled Patients, which
will be followed by thorough clinical examination.
5. Following
the screening procedure as part of this trial, the eligibility of the patient
to participate in the trial would be decided by the investigator based on the
inclusion-exclusion criteria described in the protocol.
6. Depending on the size of the dressing [5×5 or 5×10
or 10×10 or as per investigator’s discretiondepending on wound surface area],
one or two or more units of investigational product will be provided to the Patient
at each visit by the investigator at no cost. Since the trial has double-blind
study design, the patient or the investigator would not know the identity of
investigational product [Test or active-control].
7. Total
duration of the clinical trial for any patient who is randomized and enrolled will
be maximum of 12 weeks. The trial could end prior to week 12 for an individual
patient, if complete wound closure is achieved earlier. On the other hand, the
investigator could switch the patient on alternative treatment modality, if
there is no satisfactory response observed from the treatment. However, from
the enrolment in the study on day 0, the patient must complete at least 4
weeks, to qualify him/ her for the decision of switching to alternative
treatment modality due to unsatisfactory treatment response. This will not be
considered as adverse event.
8. Patients
will be instructed to prepare the reconstituted solution (ready to use
solution) as per the instructions given below.
Open
‘Bottle A’ and ‘Bottle B’.
Pour
the contents of Bottle A in to Bottle B.
Close
the bottle B with bottle cap.
Mix the content by gently moving the bottle
upside down for 5 times.
9.Patients
will be asked to use the reconstituted solution within 14 days once it is
prepared. Reconstituted solution should not be used after 14 days of mixing/
reconstitution.
10.Patient
will be instructed to use the reconstituted solution as per the instructions
given below:
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. As per size of the
dressing, the dose would vary, i.e. for 5 x 10 cm dressing (inner gauze), 7 mL
solution would be needed, whereas for 10 x 10 cm dressing (inner gauze), 14 mL
solution would be needed. Similarly, for 4 x 4 cm dressing (inner gauze), 2.5
mL solution would be needed.
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.
10.Patients
will be instructed to keep a note of daily symptoms and inform the
investigator.
11. In
case of adverse event/ serious adverse event irrespective of whether it is due
to study procedure or study drug and anytime within 12 weeks from the
enrolment, the investigator could withdraw the patient and switch to
appropriate medical or surgical management of the said AE/ SAE.
12. All
the patients will be asked to revisit the clinical trial center for efficacy
and safety assessment on day 7, day 14, day 28, day 42, day 56, day 70 and day
84. For each visit, a grace period of ± 3 days will be given to patients and
will not be considered as protocol deviation.
13. If the
CWC is achieved prior to scheduled visit, it is acceptable to ask the patient
to visit the clinical trial site for evaluation of CWC. Alternatively, if the
patient experiences any AE or SAE, he/ she could visit the clinical trial site
before the scheduled visit.
14. In
case the CWC is achieved prior to scheduled day of visit, the patient could
come to the hospital and procedures related to end-of-study [EOS] and
post-study safety assessment would be done. This, again would not be considered
as protocol deviation.
15. If the
wound is not completely healed at the end of the trial (Day 84) then it will be
decided by the investigator whether the treatment is needed and should be
continued until CWC. In this case the patient would be provided with investigational
product after opening the blind.