Addition of injection penicillin to the standard treatment of venous ulcer and its effects on healing , pain and quality of life.

A TWO ARM PARALLEL DESIGN SUPERIORITY RANDOMIZED TRIAL COMPARING PENICILLIN AND STANDARD OF CARE VS STANDARD OF CARE ALONE IN ACHIEVING COMPLETE HEALING OF LEG ULCERS IN PATIENTS WITH CHRONIC VENOUS HYPERTENSION.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022551

Enrollment

100

Registered

2019-12-30

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: I868- Varicose veins of other specifiedsites

Interventions

Intervention1: Inj benzathine penicillin: Standard of care includes lifestyle modification, exercises, wound care, compression bandaging, pharmacotherapy, endovenous procedures, etc.+ Inj Benzathine p

Eligibility

Inclusion criteria

Inclusion criteria: all cases with venous ulcer CEAP grading C6

Exclusion criteria

Exclusion criteria: cases with acte dvt, pregnancy, PAD, DM.

Design outcomes

Primary

Measure	Time frame
To compare the reduction in size of the ulcer in patients receiving standard care for chronic venous ulcer with and with out concomitant treatment with inj Benzathine penicillin 1.2 mega units IM every 14 days to prevent lymphangitis.Timepoint: weekly for 1st month followed by monthly for next 5 months	—

Secondary

Measure	Time frame
1.reduction in pain score in patients receiving standard care for chronic venous ulcer with and with out concomitant treatment with inj Benzathine penicillin 1.2 mega units IM every 14 days to prevent lymphangitis. 2. compare the quality of life in patient of chronic venous ulcer receiving standard care for chronic venous ulcer with and with out concomitant treatment with inj Benzathine penicillin 1.2 mega units IM every 14 days to prevent lymphangitis.Timepoint: weekly for 1st month followed by monthly for next 5 months	—

Measure

Time frame

1.reduction in pain score in patients receiving standard care for chronic venous ulcer with and with out concomitant treatment with inj Benzathine penicillin 1.2 mega units IM every 14 days to prevent lymphangitis. 2. compare the quality of life in patient of chronic venous ulcer receiving standard care for chronic venous ulcer with and with out concomitant treatment with inj Benzathine penicillin 1.2 mega units IM every 14 days to prevent lymphangitis.Timepoint: weekly for 1st month followed by monthly for next 5 months

—

Countries

India

Contacts

Public ContactDr Neeraj Kumar

AIIMS

neerajkgmc@gmail.com7985471502

Outcome results

None listed

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