Health Condition 1: E086- Diabetes mellitus due to underlying condition with other specified complications
Conditions
Interventions
Intervention1: Topical phenytoin 1% cream: Topical phenytoin cream (1 tongue shaped amount to be applied with finger) shall be applied over the diabetic ulcer topically once a day
Control Intervention
Sponsors
Swati Spentose Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus. 2. Single full-thickness plantar ulcer of the lower extremity (below the knee) extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA or II as defined by University of Texas Diabetic Wound Classification). 3. Chronic ulcer of at least six weeks despite appropriate wound care. 4. Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 40 cm², both inclusive. 5. Well controlled infection or cellulitis (with systemic antibiotic therapy). 6. Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test 7. Adequate arterial blood supply, to be measured by 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. 8. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing. 9. Willing to provide written informed consent before any study procedure.
Exclusion criteria
Exclusion criteria: 1. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers. 2. Active ulcer infection assessed by clinical examination and radiographic if necessary. 3. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. 4. Active osteomyelitis affecting the area of the target ulcer. 5. Poorly controlled diabetes (uncontrolled glycemia: HbA1c = 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin 6. Known connective tissue or malignant disease. 7. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy. 8. Use of any other investigational drug / device within 30 days. 9. Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days. 10. Vascular reconstruction within 8 weeks. 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. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complete ulcer healingTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to achieve complete wound closureTimepoint: 8 weeks;Percentage reduction in total ulcer surface areaTimepoint: 8 weeks;Incidence of adverse effectsTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactBhaskar Krishnamurthy
Seth GS Medical College and KEM Hospital
Outcome results
None listed