OsteomyelitisACHILLSNCT07057817
The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage
A study testing Cerament G and Standard Surgical Managment in people with Osteomyelitis and Diabetes, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Diabetes, Calcanectomy
- What is being tested?
- Cerament G and Standard Surgical Managment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 and over
- Undergoing partial calcanectomy
- Patients with Type1 or Type 2 Diabetes
- Patients will be stratified by Pulse status and eGFR
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ramy Elkady contact
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway
Stewart Walsh
About this study
Official 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)
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.
Read the detailed 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.
- Conditions
- Osteomyelitis, Diabetes, Calcanectomy
- Being tested
- Cerament G, Standard Surgical Managment
- Keywords
- Calcanectomy, Eq5d5l
- Medical subject headings
- Osteomyelitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerament GDevice
Partial Calcanectomy plus cerament G
Standard Surgical ManagmentOther
Partial Calcanectomy as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Partial Calcanectomy with Cerament G | Experimental | Patients will undergo partial calcanectomy with the application of Cerament G. Receives: Device: Cerament G |
| Standard Partial Calcanectomy | Active comparator | Patients will undergo partial calcanectomy with standard antibiotic therapy. Receives: Other: Standard Surgical Managment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Wound Healing
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
Measured: 1 months post-surgery
Rate of Wound Healing
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
Measured: 3 months post-surgery
Rate of Wound Healing
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
Measured: 6 months post-surgery
Rate of Wound Healing
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
Measured: 12 months post-surgery
Secondary outcomes (7)
Time to Wound Healing
Number of days taken to achieve full wound healing.
Measured: 1, 3, 6, and 12 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
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)
Measured: 1 month post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
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)
Measured: 3 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
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)
Measured: 6 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
Impact on patients quality of life measured using the EQ-5D-5L health questionnaire
Measured: 12 months post-surgery
Cost to Patients Questionaire (CoPaQ)
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..
Measured: 12 months post-surgery
Length of Hospital Stay
Length of hospital stay (days)
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jan 2026
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Walsh, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057817
- Sponsor's protocol ID
- RCSI-ACHILLS
- Acronym
- ACHILLS
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07057817
- Acronym / sponsor ID
- ACHILLS / RCSI-ACHILLS
- Conditions
- Osteomyelitis, Diabetes, Calcanectomy
- Keywords
- Calcanectomy, Eq5d5l
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Calcanectomy with Cerament G | Experimental | Device: Cerament GPatients will undergo partial calcanectomy with the application of Cerament G. |
| Standard Partial Calcanectomy | Active comparator | Other: Standard Surgical ManagmentPatients will undergo partial calcanectomy with standard antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 and over
- Undergoing partial calcanectomy
- Patients with Type1 or Type 2 Diabetes
- Patients will be stratified by Pulse status and eGFR
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerament GPartial Calcanectomy plus cerament G | Device | Partial Calcanectomy with Cerament G |
| Standard Surgical ManagmentPartial Calcanectomy as standard of care | Other | Standard Partial Calcanectomy |
Primary outcome
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
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
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
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
7 secondary outcomes
Time to Wound Healing
Time frame: 1, 3, 6, and 12 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
Time frame: 1 month post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
Time frame: 3 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
Time frame: 6 months post-surgery
Quality of life measured with the EQ5D5L (Health Questionnaire)
Time frame: 12 months post-surgery
Cost to Patients Questionaire (CoPaQ)
Time frame: 12 months post-surgery
Length of Hospital Stay
Time frame: 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Osteomyelitis
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
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Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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BonE and Joint Infections - Simplifying Treatment in Children Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ramy Elkady contact
James Walsh principal investigator
Beaumont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerament G and Standard Surgical Managment in people with Osteomyelitis and Diabetes, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Walsh (+353 1 809 3344, james@walshortho.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Wound Healing (time frame: 1 months post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.