A clinical trial to study the effect of dressing material BF27(PV) in patients with mild to moderate depth wound.

A Phase II, monocentric, weekly dressing of chronic wound with BF27 (PV) under dermatological control for 4 weeks to evaluate the efficacy and safety on 35 subjects with mild to moderate depth wound - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000394

Enrollment

Registered

2010-05-14

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

None listed

Interventions

Intervention1: BF27(PV): Wound care dressing material Control Intervention1: NONE: NONE

Eligibility

Inclusion criteria

Inclusion criteria: ? Subject both male and female with chronic ulcer. ? Subject age group 18 - 65 years. ? Subject has not participated in any similar clinical study in the past four weeks. ? Subject willing to give a written informed consent and come for regular follow up visits. ? Subject with chronic ulcer of 1-3 cm in diameter. ? Subject with chronic ulcer of mild to moderate depth. ? Non- infected ulcer. ? In case of diabetics, the fasting blood sugar within normal range, the well controlled recent HbA1c report. ? Subject on rescue therapy during the course of the study.

Exclusion criteria

Exclusion criteria: ? Severe infection, allergy on the tested area ? Chronic ulcer showing signs of infections with copious slough and purulent discharge ? Chronic ulcer <1 or >3 cm in size ? Subject with chronic ulcer of superficial depth as well as very deep ulcers. ? Subject on topical as well as oral antibiotics during recruitment. ? Subject with uncontrolled diabetes mellitus ? Skin allergy antecedents or atopic subjects ? Hyper sensitivity to any component of the test product. ? Cutaneous disease which may influence the study result. ? Chronic illness which may influence the cutaneous state. ? Subject on oral corticosteroid with dose >10mg/day ? Subject in an exclusion period or participating in any other cosmetic or therapeutic trial. ? Any underlying medical illness including, liver disease or history of alcoholism, HIV, or any other serious medical illness. ? Pregnant and lactating women. ? One of the criteria of non inclusion occurred during the period of observation. ? Indication of intolerance to the studied product requiring that the investigation should be stopped. ? Non respect of the protocol.

Design outcomes

Primary

Measure	Time frame
To evaluate the dermatological efficacy and safety of BF27(PV) as wound dresssing material on chronic and iatrogenic wound in 35 subjects.Timepoint: evaluated on Day 1,7,14,21,28;To evaluate the dermatological efficacy and safety of BF27(PV) as wound dresssing material on chronic and iatrogenic wound in 35 subjects.Timepoint: evaluated on Day 1,7,14,21,28	—

Secondary

Measure	Time frame
Efficacy of BF27 (PV) as wound dressing material in healing process & reduction in the size of the wound.Timepoint: 4 weeks for each subject	—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS Clinical Research Pvt. Ltd

mukta.sachdev@mscr.in08040917253

Outcome results