Calcanectomy, Diabetes, Osteomyelitis
Conditions
Keywords
Calcanectomy, Eq5d5l
Brief 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 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
DEVICECerament G
Partial Calcanectomy plus cerament G
OTHERStandard Surgical Managment
Partial Calcanectomy as standard of care
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Wound Healing | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Wound Healing | 1, 3, 6, and 12 months post-surgery | Number of days taken to achieve full wound healing. |
| Quality of life measured with the EQ5D5L (Health Questionnaire) | 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) |
| Cost to Patients Questionaire (CoPaQ) | 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.. |
| Length of Hospital Stay | 12 months post-surgery | Length of hospital stay (days) |
Countries
Ireland
Contacts
CONTACTJames Walsh
CONTACTRamy Elkady
PRINCIPAL_INVESTIGATORJames Walsh
Beaumont Hospital
Outcome results
None listed