Study to evaluate effectiveness of cream for participants with diabetic foot ulcers and bedsores.

An open-label, non-interventional, observational study of Human Placental extract Cream in patients with diabetic foot ulcers and bedsores across tertiary care centers. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075076

Enrollment

100

Registered

2024-10-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Placentrex cream: Topical 10% Human placental extract Cream Frequency: 2 times daily for a period of 12 weeks. Administration: Topical.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects aged between 40-70 years of any sex. 2. Subjects clinically diagnosed with diabetic foot ulcers and bedsores with wounds of more than two weeks duration. 3. Subjects with diabetic foot ulcers having an area not more than 5cm squire of area of ulcer and of more than six weeks duration 4. Diabetic foot ulcers ulcer should be free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining. 5. Subjects with bedsores having an area not more than 3 cm squire of area of ulcer. 6. The diabetic foot ulcers had to be clinically noninfected (Infection will be diagnosed based on clinical signs and symptoms) 7. Subjects with bedsores with wounds of more than 1 to 2 weeks duration. 8. Subjects willing for informed consent. 9. Subjects willing for regular follow up. 10. Women of childbearing age should not be pregnant or lactating.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactating mothers 2. Pediatric subjects (less than 18 years of age). 3. Subjects with diabetic foot ulcers having an area more than 5×5 cm of area of ulcer, full thickness and exposure of bone, muscle, ligaments, or tendons. 4. Subjects with chronic CVD (Coronary/Cerebro Vascular Disease), CKD - stages III and IV. 5. Ulcers with malignant aetiologies. 6. Subjects who require hospitalization. 7. Subject with history of active ulcer, active arthropathy or foot infection. 8. Subjects not willing to participate in the study.

Design outcomes

Primary

Measure	Time frame
Response to treatment is measured by percentage of patients with wound healing in the wound area. The following parameters should be considered for assessment of wound healing: Principal Investigator will assess the wound healing by visual inspection of wound at baseline and end of the study. 1. Healthy granulation tissue, 2. Absence of pus/necrotic tissue, 3. Absence of bleeding while dressing, 4. Presence of Scar tissue, 5. Absence of surrounding skin discoloration/atrophic changesTimepoint: Duration of 4 weeks. Visit 1, Visit 2, Visit 3, Visit 4.	—

Measure

Time frame

Response to treatment is measured by percentage of patients with wound healing in the wound area. The following parameters should be considered for assessment of wound healing: Principal Investigator will assess the wound healing by visual inspection of wound at baseline and end of the study. 1. Healthy granulation tissue, 2. Absence of pus/necrotic tissue, 3. Absence of bleeding while dressing, 4. Presence of Scar tissue, 5. Absence of surrounding skin discoloration/atrophic changesTimepoint: Duration of 4 weeks. Visit 1, Visit 2, Visit 3, Visit 4.

—

Secondary

Measure	Time frame
1. Safety Assessment 2. Tolerability assessment 3. Percentage reduction in the wound area 4. Time taken for wound healingTimepoint: Duration of 4 weeks. Visit 1, Visit 2, Visit 3, Visit 4.	—

Countries

India

Contacts

Public ContactDr Ashwini Kumar

Albert David Limited

veena.venkatesh@adlindia.in9930321184

Outcome results

None listed

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