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CTRI Number  CTRI/2025/11/098202 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study on the benefit of collagen particles in non-healing wounds of the leg 
Scientific Title of Study   Effect of i-Coll- collagen particles on wound healing dynamics of chronic leg ulcers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Arun Maiya  
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Room No. 1 Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr G Arun Maiya  
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Room No. 1 Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr G Arun Maiya  
Designation  Dean and Professor, MCHP 
Affiliation  Manipal College of Health Professions, MAHE, Manipal 
Address  Room No. 1 Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9845350823  
Fax    
Email  arun.maiya@manipal.edu  
 
Source of Monetary or Material Support  
IWound Global Private Limited 
 
Primary Sponsor  
Name  IWound Global Private Limited 
Address  IWound Global Private Limited No. 104, Butt road, Bazaar Street, St. Thomas Mount, Saidapet, Chennai 600016 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Arun Maiya  Kasturba Hospital  Room No. 1 Centre for Podiatry & Diabetic Foot Care and Research, Division- Baliga block, Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India
Udupi
KARNATAKA 		 09845350823

arun.maiya@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Katurba medical College and Kasturba Hospital Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L978||Non-pressure chronic ulcer of other part of lower leg,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  I coll collagen particles  Following a thorough foot examination, study participants will be asked to lie down in a supine position on the treatment bed. The assessing investigator will clean the area of the diabetic foot ulcer with saline and dried. Prior to each treatment session, a photograph of the ulcer area will be taken, as well as the ulcer area measurement, which will be traced on a transparent sheet without any direct contact with the involved site. The investigator delivering the intervention to the study participants will follow standard safety and sterile precautions throughout the procedure. i-Coll collagen particles will be applied into the wound cavity and covered with secondary dressing (gamjee pad or sterile gauze) for every 48 hours upto 21 days of study period. Throughout the intervention period, the participants will be subjected to a thorough clinical evaluation at each visit.  
Comparator Agent  Standard of Care for Chronic Leg Ulcers   Standard wound dressing: Hydrocolloid or Collagen-based dressings as standard wound dressing done for ulcers. Offloading for Weight-Bearing Ulcers: For ulcers in weight-bearing areas (like foot), Custom footwear and insoles will be provided to offload the ulcer area. Infection Control: Antibiotics or antimicrobial agents will be prescribed if infection is present.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients above 18 years of age, either
gender.
Presence of chronic non-healing foot ulcer
(Venous, pressure and diabetic foot ulcer) 
 
ExclusionCriteria 
Details  Individuals under the age of 18, those with
foot ulcers referred to surgical interventions
will be exempted from participation 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Rate of Wound Contraction   Measured as the percentage reduction in ulcer area over the treatment duration (21 days), using sequential photographic and assessment. 
 
Secondary Outcome  
Outcome  TimePoints 
Hydroxyproline and Hexosamine Content of the Wound
 		 Measured on day 14 
 
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   Phase 2 
Date of First Enrollment (India)   08/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Chronic leg ulcers, including diabetic, venous, and pressure ulcers, are major public health concerns causing significant morbidity, pain, and disability. Delayed healing in such ulcers often results from impaired collagen synthesis and tissue remodeling. Collagen-based therapies have shown promise in enhancing wound repair by supporting cellular proliferation and extracellular matrix formation.

This interventional study aims to evaluate the efficacy of i-Coll collagen particles on wound healing dynamics in patients with chronic leg ulcers. A total of 30 participants with non-healing ulcers of more than three months’ duration will be recruited and receive i-Coll collagen particle application every 48 hours for 21 days, along with standard wound care practices.

The primary outcome is the rate of wound contraction, assessed by planimetric and photographic measurements. Secondary outcomes include hydroxyproline and hexosamine content in wound swab samples, reflecting biochemical markers of collagen synthesis and healing.

It is hypothesized that i-Coll collagen particles, due to their native triple-helical protein structure, will enhance granulation tissue formation, accelerate epithelialization, and promote faster wound closure compared to standard treatment. The findings are expected to provide evidence for the therapeutic role of collagen-based formulations in chronic wound management.

 
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