Study to Evaluate Efficacy, Safety and Tolerability of Topical Ointment in Patients with Diabetic Foot Ulcer

A Topical preparation of Cayene 0.05% + Cedar wood oil 5% + Burdock oil 5% + Golden seal extract 5%+ Haldi Oil 5%+ Gandhaka 5%+ Tankana Amla 5% in oil base

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/04/013245

Enrollment

100

Registered

2018-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic Foot Ulcer Patients

Interventions

Intervention1: Topical Cream: Topical preparation of Cayene 0.05% + Cedar wood oil 5% + Burdock oil 5% + Golden seal extract 5%+ Haldi Oil 5% + Gandhaka 5%+ Tankana Amla 5% to be applied over the affe

Eligibility

Inclusion criteria

Inclusion criteria: Subject with Type 2 diabetes mellitus. Glycosylated hemoglobin (HbA1c) of >= 6.5% and Subject with wound which is either Wagner grade 1 or grade 2 Subject with wound area between 1cm2 and 16 cm2 in area Subject with Ulcer located on the foot, distal to malleoli. Adequate circulation to the affected extremity Serum creatinine of Willingness and able to give informed consent and comply with requirements for participation in the study.

Exclusion criteria

Exclusion criteria: Subject who is pregnant or Lactating Subject with Ulcer less than 1cm2 in size Subject with Ulcer greater than 16cm2 in size Severe arterial disease (ankle brachial index (ABI): 0.7 to 1.3) Toe Brachial Index >0.3 Corticosteroids use >10mg prednisone daily Subject with Ulcer of a nondiabetic pathophysiology Charcots neuroarthropathy as determined by clinical and or radiographic examination Subject with Known allergy or hypersensitivity to the components of the formulation Currently enrolled in a clinical evaluation of another investigational device or drug for diabetic foot ulcers in the last 30 days Subject receiving radiation or chemotherapy of any kind Subject with active malignant disease Subject with taking medications considered to be immune system modulators Subject unable to comply with the procedures described in the protocol

Design outcomes

Primary

Measure	Time frame
Re- epithelialization of wound as determined by the investigatorTimepoint: From Baseline to End of study	—

Secondary

Measure	Time frame
Measurement of percent wound area reduction as determined by the investigatorTimepoint: From Baseline to End of study;Measurement of percent wound area reduction as determined by the investigator Safety will be assessed based on the adverse effects as mentioned by the patient and evaluated by the investigator Tolerability will be assessed based on the adverse effects as evaluated by the investigatorTimepoint: From Baseline to End of study	—

Measure

Time frame

Measurement of percent wound area reduction as determined by the investigatorTimepoint: From Baseline to End of study;Measurement of percent wound area reduction as determined by the investigator Safety will be assessed based on the adverse effects as mentioned by the patient and evaluated by the investigator Tolerability will be assessed based on the adverse effects as evaluated by the investigatorTimepoint: From Baseline to End of study

—

Countries

India

Contacts

Public ContactDr Krishna Kumar M

Micro Labs Limited

drmanjula@microlabs.in08022370451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026