| CTRI Number |
CTRI/2025/10/096129 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on diabetic foot ulcer treatment with Diperoxochloric Acid [DPOCL] |
|
Scientific Title of Study
|
A Prospective, Open-Label, Non-Randomized, Non-Comparative Observational post marking surveillance study to test the safety and efficacy of Diperoxochloric Acid [DPOCL] topical solution in Subjects with diabetic neuropathic ulcers of skin and subcutaneous tissue. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 098-25 |
Protocol Number |
| Protocol number 098-25, Date - 24-Apr-2025, Version no. 1.0 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayuresh Kiran |
| Designation |
Vice President Medical Services, Pharmacovigilance and NPD |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola,Santacruz (E), Mumbai 400 055, Maharashtra India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609156 |
| Fax |
|
| Email |
drmayuresh@centaurlab.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Pramita Waghambare |
| Designation |
Executive Pharmacovigilance and Biomedical Reasearch |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola,Santacruz (E), Mumbai 400 055, Maharashtra India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
pramita@centaurlab.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aakansha Singh |
| Designation |
Officer Medical Services |
| Affiliation |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola,Santacruz (E), Mumbai 400 055, Maharashtra India.
Mumbai
MAHARASHTRA
400055
India |
| Phone |
02267609341 |
| Fax |
|
| Email |
med_user2@centaurlab.com |
|
|
Source of Monetary or Material Support
|
| Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, SantacruzEast, Mumbai, Maharashtra 400055 |
|
|
Primary Sponsor
|
| Name |
Centaur Pharmaceuticals Pvt Ltd |
| Address |
Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, SantacruzEast, Mumbai, Maharashtra 400055 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CENTAUR PHARMACEUTICALS PVT LTD |
Plant I, Plot No.3,5B,2C
Tivim Industrial Estate, Karaswada,
Mapusa, Goa (403 526) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayuresh Kiran |
Centaur Pharmaceutics Pvt Ltd |
Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, SantacruzEast, Mumbai, Maharashtra 400055
Mumbai
MAHARASHTRA |
02267609156
drmayuresh@centaurlab.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare Ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E104||Type 1 diabetes mellitus with neurological complications, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
WOXheal (Diperoxochloric Acid Topical Solution) |
This pack contains two bottles:
Bottle A: Diperoxochloric acid concentrate (each ml of solution contains: Diperoxochloric Acid Concentrate- 1.16 mg)
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.
Reconstituted Solution (Bottle A + Bottle B) in bottle B:
Each ml of solution contains:
Diperoxochloric acid - 0.29 mg
Total duration of the study will be of 70 days. At day 0, patient/ patients guardian will be informed about the observational post marketing survillence study. All the patients will be asked to revisit the clinical trial centre 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. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients diagnosed with either Type I or II diabetes mellitus.
2)Patients having random blood sugar [RBG] of Less than 250 mg/dL on standard anti-diabetic treatment
3)Patients having glycosylated hemoglobin of less than 12%.
4)Age: more than 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) Patients with Ankle-Brachial Pressure Index [ABPI] more than 0.7
8) All the patients willing to voluntarily participate in the clinical trial and signing on duly filled Informed Consent Form.
|
|
| ExclusionCriteria |
| Details |
1) Patients with more than 3 ulcers.
2) Patients 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) Patients having history of active Charcoat’s foot of the study foot within 6 months of screening.
7) Patients having severe or poorly controlled diabetes mellitus with severe hyperglycemia (RBG more than 250 mg/dL).
8) Patients having glycosylated hemoglobin of more than 12%.
9) Patients 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 more than 3mg /dL) liver failure, malignancy.
12) Revascularization surgery performed less than 8 weeks before entry in the study.
13) Pregnant or nursing mothers.
14) Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
15) Patients with Ankle-Brachial Pressure Index [ABPI] less than 0.7
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Percentage of patients achieving Complete Wound Closure (CWC).
2.Percentage reduction in the wound surface area at each visit.
3.Patients with more than or equal to 25% reduction in wound surface area will be continued in the treatment and will be defined under treatment responders.
4. An improvement in percentage change in wound surface area after 4 weeks (Day 28) of treatment is a strong predictor of complete healing.
5.No. of days taken for complete wound closure from onset of wound.
|
at every visit that
is week 1 week 2
week 3 week 4
week 6 week 8
and week 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical examination of ulcer – Wound Evaluation Score, which will consists of six parameters (erythema, edema, purulence, necrotic tissue, fibrin and pain) scored on 4 point visual analogue scale from 0 to 3 where 0 is no symptom, 1 is mild,2 is moderate and 3 is severe intensity symptom.
2. Quality of life will be assessed by Karnofsky Performance Status (KPS) Scale |
at every visit that is
week 1 week 2 week 3
week 4 week 6 week 8
and week 10 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 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, Non-Randomized, Non- Comparative, Observational Post-Marketing
Surveillance study 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 on 30 patients. The total
duration of the clinical trial will be of 70 days. At day 0, patient/ patients
guardian will be informed about the ‘’Observational 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. All the
patients will be asked to revisit the clinical trial center for efficacy and
safety assssment 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 m 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 |