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NCT Number: NCT07057817

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

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.

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Key information

Conditions

Osteomyelitis Bone Diseases Bone Diseases, Infectious Calcanectomy Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Galway

Galway, Ireland

Location status: Recruiting

Location contact

Stewart Walsh

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CERAMENT G

Device

Partial Calcanectomy plus cerament G

Standard Surgical Managment

Other

Partial Calcanectomy as standard of care

Primary outcomes

  1. Rate of Wound Healing

    Time frame: 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

  2. Rate of Wound Healing

    Time frame: 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

  3. Rate of Wound Healing

    Time frame: 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

  4. Rate of Wound Healing

    Time frame: 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

Secondary outcomes

  1. Time to Wound Healing

    Time frame: 1, 3, 6, and 12 months post-surgery

    Number of days taken to achieve full wound healing.

  2. Quality of life measured with the EQ5D5L (Health Questionnaire)

    Time frame: 1 month post-surgery

    Impact on patients quality of life measured using the EQ-5D-5L health questionnaire. The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  3. Quality of life measured with the EQ5D5L (Health Questionnaire)

    Time frame: 3 months post-surgery

    Impact on patients quality of life measured using the EQ-5D-5L health questionnaire, The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  4. Quality of life measured with the EQ5D5L (Health Questionnaire)

    Time frame: 6 months post-surgery

    Impact on patients quality of life measured using the EQ-5D-5L health questionnaire, The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)

  5. Quality of life measured with the EQ5D5L (Health Questionnaire)

    Time frame: 12 months post-surgery

    Impact on patients quality of life measured using the EQ-5D-5L health questionnaire

  6. Cost to Patients Questionaire (CoPaQ)

    Time frame: 12 months post-surgery

    Measures patients' and caregivers' out-of-pocket expenses (e.g., travel) and indirect costs (e.g., loss of income). It is divided into two sections 1. Costs for Patients Questionnaire and 2. Sociodemographic and Health Questions..

  7. Length of Hospital Stay

    Time frame: 12 months post-surgery

    Length of hospital stay (days)

Study contacts

Contact information is provided by the study sponsor or research team.

James Walsh

CONTACT

[email protected]

+353 1 809 3344

Ramy Elkady

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study title

Randomised Controlled Trial Comparing Partial Calcanectomy Plus Local Application Antibiotic Impregnated Bone Graft Substitute for Calcaneal Osteomyelitis vs Partial Calcanectomy Alone (The ACHILLS Trial)

Acronym: ACHILLS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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