The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage

NCT07057817 · tracked via the Priya Life Science Ireland tracker

Sponsor

Royal College of Surgeons, Ireland

Phase

Not applicable

Started

2026-01-01

Last updated

2026-07-22

Condition(s) studied

OsteomyelitisDiabetesCalcanectomy

Investigational drug(s) / intervention(s)

Cerament GStandard Surgical Managment

Cerament G: Partial Calcanectomy plus cerament G

Standard Surgical Managment: Partial Calcanectomy as standard of care

Study summary

The ACHILLS Trial is a multicentre randomised controlled feasibility study comparing partial calcanectomy with and without the use of an antibiotic-impregnated bone graft substitute (Cerament G) for treating calcaneal osteomyelitis, specifically on wound healing rates, re-infection, and overall efficacy in a sample of 30 patients over a one-year period.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 18 and over * Undergoing partial calcanectomy * Patients with Type1 or Type 2 Diabetes * Patients will be stratified by Pulse status and eGFR Exclusion Criteria: * Patients unfit for surgery * Patients unable to provide informed consent * Patients with overwhelming sepsis that require major amputation * Patients with hypersensitivity to aminoglycosides * Pre-existing calcium metabolism disorder * Severe renal impairment * Patients in whom major limb amputation is deemed inevitable by the treating physician

Primary outcome measure(s)

Rate of Wound Healing — 1 months post-surgery
To determine the number of patients achieving complete wound healing in patients undergoing treatment with cerament G compared to those with partial calcanectomy alone by measuring wound volume
Rate of Wound Healing — 3 months post-surgery
To determine the number of patients achieving complete wound healing in patients undergoing treatment with cerament G compared to those with partial calcanectomy alone by measuring wound volume
Rate of Wound Healing — 6 months post-surgery
To determine the number of patients achieving complete wound healing in patients undergoing treatment with cerament G compared to those with partial calcanectomy alone by measuring wound volume
Rate of Wound Healing — 12 months post-surgery
To determine the number of patients achieving complete wound healing in patients undergoing treatment with cerament G compared to those with partial calcanectomy alone by measuring wound volume

Trial sites (1)

Facility	City	Region	Status
University Hospital Galway	Galway	Ireland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07057817 on ClinicalTrials.gov ↗ ← All trials in Ireland