The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerament G, Standard Surgical Managment.
- Who it may be relevant to
- Registry conditions: Osteomyelitis, Diabetes, Calcanectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Device Cerament G
Partial Calcanectomy plus cerament G - Other Standard Surgical Managment
Partial Calcanectomy as standard of care
Primary outcome measures
- Rate of Wound Healing [Time frame: 1 months post-surgery]
- Rate of Wound Healing [Time frame: 3 months post-surgery]
- Rate of Wound Healing [Time frame: 6 months post-surgery]
- Rate of Wound Healing [Time frame: 12 months post-surgery]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Ireland · 1 center
- University Hospital Galway — Galway
Identifiers
NCT: NCT07057817 · RCSI-ACHILLS