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

Royal College of Surgeons, Ireland

Status: Not yet enrolling

Conditions: Diabetes; Osteomyelitis; Calcanectomy

Treatments: Device: Cerament G; Other: Standard Surgical Managment

Study type: Interventional

Funder types: Other

Identifiers

NCT07057817

RCSI-ACHILLS

Details and patient eligibility

About

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.

Full description

Calcaneal osteomyelitis is a severe infection of the heel bone, frequently linked to peripheral arterial disease and diabetes, which complicates the healing process. This condition can lead to chronic wounds, persistent pain, and, in extreme cases, the need for limb amputation. Standard treatment often involves partial or total calcanectomy, where the infected bone is surgically removed, significantly impacting patients' mobility and quality of life.

The ACHILLS Trial is a multicentre, randomised controlled feasibility study designed to assess the efficacy of partial calcanectomy with and without the use of Cerament G, an antibiotic-impregnated bone graft substitute.

The primary objective is to determine the rate of wound healing in patients undergoing partial calcanectomy for osteomyelitis who receive Cerament G.

Secondary objectives include assessing time to wound healing, rates of re-infection, hospital stay duration, need for extended antibiotic therapy, financial impact, and overall quality of life.

The trial will involve 30 participants, aged 18 and older, undergoing partial calcanectomy for osteomyelitis. Participants will be randomly assigned to one of two groups: one receiving partial calcanectomy with Cerament G, and the other receiving partial calcanectomy alone with standard antibiotic therapy. The study will monitor patients for one year, with data collected at multiple intervals to monitor wound healing, re-infection rates, and other outcomes.

Cerament G, comprising calcium sulphate and hydroxyapatite, serves as a bone substitute and delivers a localised antibiotic (gentamycin) directly to the infection site. This approach aims to reduce infection rates, promote bone healing, and minimise the need for further surgical interventions.

The results from this feasibility study may result in a larger trial, potentially leading to improved management strategies for calcaneal osteomyelitis, reduced healthcare costs, and enhanced patient outcomes.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Partial Calcanectomy with Cerament G

Experimental group

Description:

Patients will undergo partial calcanectomy with the application of Cerament G.

Treatment:

Device: Cerament G

Standard Partial Calcanectomy

Active Comparator group

Description:

Patients will undergo partial calcanectomy with standard antibiotic therapy.

Treatment:

Other: Standard Surgical Managment