Post Marketing Study to Evaluate the Safety & Efficacy of Sterile Collagen Particles in Chronic diabetic Foot ulcers.
- Conditions
- Health Condition 1: E135- Other specified diabetes mellituswith circulatory complications
- Registration Number
- CTRI/2023/01/048699
- Lead Sponsor
- Eucare Pharmaceuticals P Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
1.Male/ female patient more than 18 years and less than70 years of age.
2.Patient who can and willing to provide written Informed Consent.
3.Patient with Chronic foot ulcers (diabetic foot ulcers) which extend into the papillary (shallow) dermis, or into the reticular (deep) dermis, or into subcutaneous fat, but not extending into muscle, tendon, capsule, or bone.
4.Patients with HbA1c less than 8.5%.
5.Index ulcer (i.e., current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
6.Index ulcer is a minimum of 1 cm2 and a maximum of 25cm2 at first treatment visit.
7.The index ulcer has been offloaded for at least 7 days prior to enrolment.
8.Patient understands and is willing to participate in the clinical study and can comply with regular treatment visits and the follow-up regimen.
1. Patient with known allergy/hypersensitivity to collagen or other fish derived products.
2. Patient having a medical or social condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol.
3. Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration.
4. Patients treated with wound dressings that include growth factors, bioengineered tissues, or skin substitutes other than the study material, within 30 days of the screening visit and throughout the study.
5. Patients with a history of more than two weeks treatment with immunosuppressants, cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first screening visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
6. Presence of any condition(s) which seriously compromises the patient’s ability to complete this study or has a known history of poor adherence with medical treatment.
7. Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
8. Conditions which will interfere the wound healing process are malignancy, connective tissues disorders, immune system disease.
9. Patient with suspected osteomyelitis prior to enrolment.
10. Pregnant or lactating females.
11. Patient unwilling or unable to comply with the study requirement for offloading the index ulcer.
12. Index ulcer has reduced in area by >20% within 2 weeks prior to enrolment
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoints <br/ ><br> <br/ ><br> a) Number of Treatment Emergent Adverse Events. <br/ ><br> b) Recurrence of infection/deterioration of the <br/ ><br> wound. <br/ ><br> c)Hypersensitive/allergic reactions towards the study product.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary Endpoints <br/ ><br> <br/ ><br> a) Change in wound surface area from baseline to End of study visit Week 12 Time frame 12 weeks. <br/ ><br> b) Time (in days) required for achieving clinically satisfactory wound healing (progress of wound healing). <br/ ><br>c) Time (in days) taken for the onset of granulation.Timepoint: 12 weeks