CTRI/2018/07/014734
Suspended
Phase 2
Evaluation of Efficacy and Safety of AHPL/AYTOP/0113 cream in Patients Suffering from Diabetic Foot Ulcer: A randomized, open label, multicentric, interventional, prospective comparative, clinical study. - NI
Ari Healthcare Pvt Ltd R D Centre0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Diabetic Foot Ulcer
- Sponsor
- Ari Healthcare Pvt Ltd R D Centre
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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