Health Condition 1: null- Patients with chronic wounds such as diabetic ulcers or pressure ulcers or venous leg ulcers Health Condition 2: L896- Pressure ulcer of heel
Conditions
Interventions
Intervention1: Dexadine Ointment: Dexadine ointment to be applied on the wound depending on the wound exudate daily once for first 4 weeks and then once in three days from 5 to12 weeks or till complet
Sponsors
Virchow Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women aged between18 and 65years, with venous leg ulcer or diabetic foot ulcers or pressure ulcers. 2. Venous ulcer a. Venous ulcer of atleast four weeks despite appropriate wound care. Venous ulcer area (greatest length by greatest width), following sharp debridement, of 5 to 10 cm², both inclusive. b. Have been prescribed compression for atleast 7 consecutive days immediately prior to randomization c. Have evidence of venous insufficiency documented by venous duplex scanning or impedance plethysmography. d. Adequate arterial blood supply, to be measured by ankle brachial pressure index >= 0.8 or 3. Diabetic foot ulcer a. Single full-thickness plantar ulcer of the extremity (below the malleolus) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification). Chronic ulcer of at least four weeks despite appropriate wound care. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive. b. Well controlled infection or cellulitis (systemic antibiotherapy). c. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold). d. Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index > 0.60, or ankle systolic pressure > 70 mmHg or toe pressure > 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification. Or 4. Chronic pressure ulcers of at least 4 weeks (4-8 weeks); stage 1 or 2 pressure ulcers of 2 to 10 cm2 5. Women surgically sterile, post-menopausal, or those who agree to practise adequate contraception and have a negative pregnancy test at screening. Non-nursing women. 6. Signed informed consent before any study procedure is initiated.
Exclusion criteria
Exclusion criteria: 1. Ulcer located below the malleolus, on the foot or above the base of the knee. 2. Active ulcer infection 3. Diabetes (uncontrolled glycemia: HbA1c >= 9%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin 4. Known connective tissue or malignant disease. 5. Concomitant treatment with corticosteroids, 6. immunosuppressive agents, radiation therapy, or anticancer chemotherapy. 7. Use of investigational drug/device within 30 days. 8. Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 30 days. 9. Surgical procedure to treat venous or arterial disease within the last 4 weeks. 10. Patients with hypersensitivity to cadexomer iodine. 11. 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. 12. Patient with Hashimotoâ??s thyroiditis. 13. Patient with a history of Graves disease or non-toxic nodular goiter. 14. Patient with a history of thyroid disorder who is susceptable to alteration in thyroid metabolism with chronic cadexomer iodine therapy. 15. Patient with cardiovascular disease or intermittent claudication or stroke. 16. Patient with human immunodeficiency virus (HIV) infection. 17. Active ulcer infection assessed by clinical examination and radiographically if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of reduction in ulcer size from baseline to 12 weeksTimepoint: 1. Percentage of reduction in ulcer size from baseline to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in ulcer size from baseline to 12 weeks.Timepoint: 12 weeks;2. Proportion of ulcers healed within 12 weeks (Complete healing is defined as full 100% epithelialisation or skin closure without drainage) Timepoint: 12 weeks;3. Mean change in wound evaluation score (edema, pain, exudates, erythema and pus) from baseline to 12 weeks.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Virchow Biotech Private Limited
Outcome results
None listed