Health Condition 1: E136- Other specified diabetes mellituswith other specified complications
Conditions
Interventions
Intervention1: Nitric Oxide Patch (ColoNox): Apply Nitric Oxide Patch (Colonox) every after 2 days for 50 days
Control Intervention1: Collagen Dressing (ColloGraft): Apply Collagen Dressing (Collograf
Sponsors
Cologenesis Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Adult, male and female patients of age between 18-75 years with a Body Mass Index (BMI) Capacity of attending the visits at the research site. Confirmed diagnosis of Diabetic Mellitus type 1 or 2 according to the Guidelines from the American Diabetes Association (ADA). Wound debrided properly by surgical method. Single wound ulcer with or without presence of sign and symptom of any infection. Considering single diabetic foot ulcer not more than 10cm2 after post debridement. As per The University of Texas Staging System for Diabetic Foot Ulcers, with Associated Interventions score with = Grade II (A & B) Glycosylated hemoglobin (HbA1c) of =12%. Wound which has Meggitt–Wagner classification of Foot Ulcers Grade 1 or Grade 2 (without bone, tendon or joint exposure), duration of >14 days Ulcer located on the foot, distal to malleoli. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing. Signed informed consent before any study procedure.
Exclusion criteria
Exclusion criteria: 1. History of allergy or hypersensitivity reactions to Nitric oxide or any related compound. 2. Uncontrolled Type 1 & 2 DM, HbA1c of > 12%. 3. Any pathology that, based on the judgment of the researcher, could alter the course of Diabetic Foot Ulcer (neoplasias, immunological disorders, etc.). 4. Renal insufficiency requiring dialysis treatment. 5. Diabetic Foot Ulcer with a Texas score > Grade II. 6. Diabetic Foot Ulcer with clinical or paraclinical findings suggesting osteomyelitis. 7. Critical ischemia of Ischemic Limb diagnosed by Doppler ultrasound and defined by ankle-brachial index 8. Clinical findings suggesting complicated venous insufficiency of Ischemic Limb. 9. Distal necrosis of the limb with the ulcer. 10. Pregnant or breastfeeding women. 11. Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study. 12. Refusal to give informed consent. participated in another clinical trial within 30 days prior to consent. 13. Active Charcot deformity of the study foot (i.e., erythematous, warm, edematous and actively remodelling). 14. Receiving radiation or chemotherapy of any kind. 15. Known or suspected malignancy of current ulcer. 16. An active malignant disease. 17. Sickle cell anaemia or Raynaud’s syndrome. 18. Received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent. 19. Topical application of any advanced wound care on this wound (Growth Factor, antiseptics, antibiotics) within 2 days. 20. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean percentage reduction of ulcer area from baseline to visit 5 (Day 15). 2. Percentage of the patient with complete ulcer closure at visit 5(Day 15).Timepoint: 1. Mean percentage reduction of ulcer area from week 1 to week 7. 2. Percentage of the patient with complete ulcer closure at week 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of the patient with complete ulcer closure at end of study visit. 2. Mean percentage reduction of ulcer area from baseline to end of study visit. 3. Average time required to complete closure of wound ulcer. (Those with 100% wound reduction). 4. Presence of adverse events related to the application of the patches. 5. Treatment emergent clinical and laboratory adverse events (TEAE’s).Timepoint: 1. Percentage of the patient with complete ulcer closure at week 7. 2. Mean percentage reduction of ulcer area from week 1 to week 7. 3. Average time required to complete closure of wound ulcer. (Those with 100% wound reduction). 4. Presence of adverse events related to the application of the patches. 5. Treatment emergent clinical and laboratory adverse events (TEAE’s). | — |
Countries
India
Contacts
Public ContactR Krishnakumar
Mediclin Clinical Research
Outcome results
None listed