Health Condition 1: null- Diabetic Foot Ulcer
Conditions
Interventions
Intervention1: AHPL/AYTOP/0113� cream:
: Each gm of cream contains % of ingredients (w/w) Jatyadi Taila (Classical Ayurvedic Formulation), Ashvattha Extract, (Ficus religiosa), Nyagrodha Ext
Sponsors
Ari Healthcare Pvt Ltd R D Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1). Male and female subjects above 30 years of age 2). Both type I and type II diabetic patients with diabetic foot ulcer 3). Diabetic patient who is under regular treatment for diabetes and having HbA1C level less than 12 4) Diabetic Foot Ulcer with less than 2 grade on University Of Texas Classification Of Diabetic Foot 5) Foot ulcer that has remained open without healing and not shown improvement for more than 3 months 6) Patients who can make all necessary visits in 90 days period and comply with the study procedures. 7) Patients willing to participate in clinical trial and who have read understood and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1)Patients with foot gangrene that needs amputation. 2)Presence of osteomyelitis in affected foot that needs antibiotic therapy during the study. 3)Patients who prefer to receive the treatment out of the study 4)Receiving drugs which may interact with the study therapeutic protocol such as glucocorticoids, immunosuppressive and cytotoxic drugs. 5)Patient having addiction of alcohol or smoking or tobacco chewing 6)Patients having any major systemic disease other than diabetes such as genetic, endocrinal diseases, hematological disorders, Pulmonary tuberculosis, HIV, AIDS, cancers, congestive heart failure, end stage renal disease and liver failure etc. that may affect the healing of ulcers. 7)Patient under treatment of diabetic foot ulcers with systemic steroids within three months before study entry. 8)Pregnant or lactating women 9)Patients having known hypersensitivity to ingredients used in study drug 10)Patient with uncontrolled Hypertension, hypothyroidism and hyperthyroidism 11)Other conditions, which in the opinion of the investigators, make the patient unsuitable for enrollment or could interfere with his her participation in, and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in surface area of ulcer using MOWA application for android and percentage healing of ulcerTimepoint: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in percentage of granulation tissue, necrotic tissue and fibrous tissue 2.Changes in proportion of cases with completely healed ulcers. 3.Number of days required for complete healing of the ulcer. 4.Evaluation of ulcer healing process by using wound healing parameters 5.Evaluation of frequency of rescue medications used 6.Assessment of overall improvement by patient and physician. 7.Assessment of adverse events 8.Changes in pre and post treatment lab investigations. Timepoint: Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed