An interventional study of Cerament G and Standard Surgical Managment in Osteomyelitis, Diabetes and Calcanectomy, sponsored by Royal College of Surgeons, Ireland. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Royal College of Surgeons, Ireland · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Osteomyelitis; 30 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 60 interventional studies indexed under Osteomyelitis.
Browse Osteomyelitis studies →Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo partial calcanectomy with the application of Cerament G.
Device: Cerament G
Patients will undergo partial calcanectomy with standard antibiotic therapy.
Other: Standard Surgical Managment
Partial Calcanectomy plus cerament G
Partial Calcanectomy as standard of care
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months post-surgery
Time to Wound Healing
Number of days taken to achieve full wound healing.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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..
Time frame: 12 months post-surgery
Length of Hospital Stay
Length of hospital stay (days)
Time frame: 12 months post-surgery
Plan to share: No
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Royal College of Surgeons, Ireland