The ACHILLS Trial; Application of Cerament in Heel Infection for Lower Limb Salvage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 and over
Undergoing partial calcanectomy
Patients with Type1 or Type 2 Diabetes
Patients will be stratified by Pulse status and eGFR
Disqualifiers
Patients unfit for surgery
Patients unable to provide informed consent
Patients with overwhelming sepsis that require major amputation
Patients with hypersensitivity to aminoglycosides
Trial design
Design model
Parallel
Treatments tested in this trial
Cerament G
DevicePartial Calcanectomy plus cerament G
Standard Surgical Managment
Other interventionPartial Calcanectomy as standard of care
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Partial Calcanectomy with Cerament GExperimental treatment 1 intervention
Group B: Standard Partial CalcanectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-surgery2
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-surgery3
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-surgery4
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-surgerySecondary outcomes
1
Time to Wound Healing
Number of days taken to achieve full wound healing.
Time frame
1, 3, 6, and 12 months post-surgery2
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-surgery3
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-surgery4
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-surgerySponsors and contacts
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Source ClinicalTrials.gov