Treatment of wounds on foot in diabetes or arterial disease with your own blood product and daily care.

EVALUATION OF ROLE OF PLATELET RICH PLASMA IN HEALING OF CHRONIC DIABETIC AND PERIPHERAL ARTERIAL DISEASE ULCERS AS COMPARED TO STANDARD MEDICAL CARE: A RANDOMIZED CONTROLLED TRIAL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033560

Enrollment

Registered

2021-05-12

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: I738- Other specified peripheral vascular diseases

Interventions

Intervention1: First arm will receive platelet gel application topically to wound and PRP injection in and around the wound (derived from autologous source) along with standard care. : 10 to 15 ml of

Eligibility

Inclusion criteria

Inclusion criteria: 1.All patients, in the age group 18-70 yrs. with diabetic ulcers, peripheral arterial disease ulcers with non reconstructable disease 2.Patients who will provide written informed consent. 3.Patients with a non-healing ulcer of at least six weeks. 4.Wound measurement up to 10 cm in largest dimension.

Exclusion criteria

Exclusion criteria: 1.Patients who are unwilling to provide informed consent. 2.Peripheral venous disease in the lower limbs. 3.Recent deep venous thrombosis (DVT). 4.Uncontrolled Diabetes mellitus (HbA1C >9%). 5.Pregnancy. 6.Any malignancy. 7.Platelets count less than 2 lacs. 8.Patients with severe cardiovascular disorder (NYHA grade III &IV). 9.Gangrene of foot or digits of the foot. 10.Grossly infected, necrotic wounds and with cellulitis. 11.Allergy to iodinated dyes or any dye. 12.Newly diagnosed/Known case of liver disease

Design outcomes

Primary

Measure	Time frame
Rate of ulcer healing measured as change in the ulcer areaTimepoint: Patients will be followed weekly for 4 weeks and once in two weeks for next 3 months or till complete healing of ulcer or amputation.	—

Secondary

Measure	Time frame
1.To compare the change in pain score [on a scale of 0-10 using Visual Analogue Scale (VAS)] 2.To measure change in regional perfusion using ICG angiography 3.To record the incidence of adverse events 4.To compare the change in quality of life [using WHOQOL]Timepoint: Patients will be followed weekly for 4 weeks and once in two weeks for next 3 months or till complete healing of ulcer or amputation.	—

Measure

Time frame

1.To compare the change in pain score [on a scale of 0-10 using Visual Analogue Scale (VAS)] 2.To measure change in regional perfusion using ICG angiography 3.To record the incidence of adverse events 4.To compare the change in quality of life [using WHOQOL]Timepoint: Patients will be followed weekly for 4 weeks and once in two weeks for next 3 months or till complete healing of ulcer or amputation.

—

Countries

India

Contacts

Public ContactDr Anita Dhar

All India Institute of Medical Sciences

dranitadharbhan@gmail.com9810198239

Outcome results

None listed

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