Lower limb BTM study

• Research type

  Research Study

• Full title

  Lower Limb Biodegradable Temporising Matrix Study

• IRAS ID

  364188

• Contact name

  Ankur Thapar

• Contact email

  a.thapar@nhs.net

• Sponsor organisation

  Mid & South Essex NHS Trust

• Duration of Study in the UK

  2 years, 1 months, 28 days

• Research summary

  Background
  Surgical lower limb wounds in vascular, orthopaedic and podiatric surgery sometimes cannot be closed. These open wounds take on average 6 months to heal with standard dressings 20% of wounds do not heal after 1 year. Biodegradable temporising matrix (BTM) is a cheap, synthetic, absorbable skin substitute that has been used for years in reconstructive surgery. Feasibility data suggests wound healing occurs around 3+ months in lower limb wounds.

  Aim
  Pilot study to establish the time taken for wound healing using BTM and to compare this to data in the literature for standard dressings.

  Design
  This is a prospective registry of 35 patients recruited over 12months from Mid&South Essex NHS Trust and Essex Partnership University NHS Trust. Trained specialists from vascular, orthopaedic and podiatric surgery will perform the BTM treatment as part of standard patient care.

  Population
  Adults with open lower limb wounds following surgery, <6 weeks old, which are unsuitable for simple closure and who have been treated with BTM.

  Comparator
  Days to healing in the literature for standard wound dressings from SWHSI-2 RCT.

  Primary outcome
  Days to wound healing

  Secondary outcomes
  Graft loss, % healed in 1 year, mobility, re-ulceration, quality of life, surgical site infection, re-intervention.

  Process outcomes
  Eligibility rate, participation rate, withdrawal rates, immediate use of topical negative pressure over BTM graft, days to delamination of graft.

  Participants will enrol during the admission for BTM application. They will have a monthly phone call from the research team to check if they have healed, or if there have been any infections or surgical procedures required. When wound healing is reported by the participant or at a follow-up phone call, a face-to-face visit will be organised to photograph and confirm wound healing.

  Structured interviews will be held with participants who consent to explore their wound healing journey and perception of treatment with BTM and how it impacted on their life and activities.
  

• REC name

  West of Scotland REC 5

• REC reference

  26/WS/0071

• Date of REC Opinion

  22 Jun 2026

• REC opinion

  Further Information Favourable Opinion