TABLE Trial

Trial of Autologous Blood products to promote ulcer Healing in LEprosy (TABLE)

The TABLE trial is looking at the treatment of leprosy ulcers that are sufficiently severe to require hospital admission.

It will take place in one centre only – Anandaban Hospital, The Leprosy Mission Nepal in Kathmandu, Nepal.

LATEST NEWS

The TABLE Trial opened to recruitment on 17th September 2020.

Design

TABLE will evaluate treatment based on the application of autologous blood products (L-PRF) or normal saline.

The RCT is a single blinded, randomised controlled trial where participants will be randomised in a 1:1 ratio to the intervention arm or standard of care arm. 130 participants will be randomised in total.

 

Aim of the Study

The aim of the study is to ascertain if treatment with autologlous blood products enables the ulcers to heal quicker.

Setting

Suitable patients will be identified at Anandaban Hospital, Nepal.

Target Population

Adult patients admitted to hospital with a leprosy ulcer in the range of 2-20 square centimetres.

Intervention

Leukocyte and Platelet-Rich Fibrin (L-PRF) applications at the time of the dressing changes twice a week. The control arm will have their dressings changed but with standard saline.

Measurement of outcomes


The main outcome and primary objectives of the trial are:

  • Rate of healing as assessed by photographs taken in a standardised manner and assessed by two blinded assessors.
  • Percentage of wounds healed (re-epithelialization) by 42 and 70 days.

Secondary objectives

  • Generic quality of life, measured fortnightly.
  • Recurrence of treated ulcer.
  • Appearance of new ulcer.
  • Anatomical changes in the limb.
  • Days hospitalised prior to discharge and total by 6 months.
  • Number of visits to any healthcare facility from discharge to the end of follow up at 6 months.
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