Clinical study to evaluate the efficacy and safety of polyherbal oil in subjects with diabetic non healing wound.

Completed

• Conditions: Other specified diabetes mellituswith other specified complications,

• Registration Number: CTRI/2019/09/021095
• Lead Sponsor: THINQ Pharma CRO Ltd

Brief Summary

**This is a multicenter, randomized, open label, parallel-group, comparative, prospective clinical study to evaluate the efficacy and safety of polyherbal oil in subjects with diabetic non healing wound.**

**Following screening, eligible patients will be randomly assigned in 1:1 ratio to one of the two treatment arms i.e. test arm or comparator arm.**

**Study Population: Male and female patients with chronic non healing diabetic wound with more than 10 days aged between 25 and 75 years will be eligible for this multi-center, open-label, comparative, randomized study. All patients must have wound size (area) is ≤ 25 cm2 (Post-debridement) measured by a standardized scale at the screening visit. All patients will undergo a complete physical examination at screening, including routine laboratory tests.**

**Study Procedures & precautionary measures:  Subjects meeting all entry criteria will be randomized at Randomization Visit (Day 1). Test product or comparator will be dispensed and applied during this visit as per randomization schedule. There will be a seven study assessment visits on Day -7 (screening),  Day 1 (baseline), Day 9(±2), Day 18(±2), Day 27(±2), Day 36(±2) and Day 45 (±4)) and site visit for IP application and dressing on day 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, and day 45.**

**The photograph/s of targeted wound is to be taken at scheduled assessment visits, with specific technique i.e. a standard digital camera should be used and must remain constant throughout the treatment period. Distance to the affected area preferably be decided by investigator and must remain constant for all subjects being treated at the clinic.**

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• 1.Subjects, male or female, aged 25 to 75 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for Glycemic control.
• 2.Subject has glycosylated Hemoglobin, HbA1C, ≤ 10% 3.Subject with diagnosis of diabetic non healing wound.
• 4.Wound size (area) is ≤ 25 cm2 (Post-debridement) at the screening visit.
• 5.There is a minimum 3 cm margin between the qualifying Target wound and any other wound on the specified body part, post-debridement.
• 6.Unresponsive to wound care and open for at least 10 days at the time of the Screening Visit.
• 7.Wound is non-infected as determined by clinical assessment and complete hemogram (CBC).
• 8.Subject, if female of child-bearing potential, has a negative urine pregnancy test at Screening and willing to use acceptable methods of contraception (birth control pills, barriers) or abstinence throughout the Study.
• 9.Subject is able and willing to comply with Study Procedures and adhere to protocol during the Study in the opinion of Investigator.
• 10.A Subject or LAR agrees to sign informed consent form.

Exclusion Criteria

• 1.Evidence of the ulcer extending to the underlying muscle, tendon, bone, ligament, Joint capsule or sinus tracts.
• 2.Actively infected wound with exposed bone.
• 3.Subject has ulcers caused by a disease other than diabetes e.g., malignant ulcerations, and ulcerations due to venous or arterial insufficiency, in the opinion of the Investigator.
• 4.Ulcer, about which the Investigator is suspicious for cancer.
• 5.Subjects with a gangrenous or ischemic ulcer.
• 6.Subject with ulcer that in the opinion of the Investigator, may need amputation.
• 7.Subject with Target wound where wound measurement is not possible, such as ulcers between toes.
• 8.Laboratory values at Screening of: Hemoglobin < 8.0 g/dL, White Blood Cells (WBC) < 2.0 X 109 cells/L.
• 9.Presence of any existing clinically significant medical condition(s) that, in the opinion of the Investigator, could interfere with wound healing, Including but not limited to the following., Connective tissue disease, Peripheral vascular disease, Clinically significant claudication or peripheral edema on the affected limb, Acute or unstable Charcot foot, Aplastic anemia or exacerbation of sickle cell anemia, Current sepsis, End-stage renal disease, Immunosuppression, Any malignancy history 10.Subject has received or is currently receiving or scheduled to receive any of following medication or therapies during the course of the Study, Immune suppressants (chronic systemic corticosteroids) within 30 days of randomization visit, Revascularization surgery (e.g., angioplasty, Coronary artery bypass surgery, transmyocardial revascularization) within 30 days of randomization visit, Growth factors within 30 days of randomization visit, Bioengineered tissue or skin substitutes within 30 days of randomization visit, Application of topical steroids to the ulcer surface within 30 days of randomization visit, Use of any investigational drug(s) or therapies within 30 days of randomization visit, Use of anti-inflammatory medication after screening visit.
• 11.Has any other factor which may, in the opinion of the Investigator, compromise participation and/or follow-up in the Study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in wound size and granulation	45 days from Baseline

Secondary Outcome Measures

Name	Time	Method
Change in reduction of exude, change in scale of pain assessment, change in wound closure and scale of edema and change in proliferation of epithelialization	45 days from Baseline

Trial Locations

Locations (5)

Ashwin Medical Foundation’s Moraya Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Global Hospital and Research Institute; 🇮🇳 Pune, MAHARASHTRA, India

Government Medical College & Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Harmony Health Hub; 🇮🇳 Nashik, MAHARASHTRA, India

Shashwat Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ashwin Medical Foundation’s Moraya Multispeciality Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Mukund Diggikar

Principal investigator

09325398011

msdiggikar@gmail.com