NCT07057817

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

June 30, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

July 25, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Last Updated

August 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 30, 2025

Last Update Submit

July 30, 2025

Conditions

OsteomyelitisDiabetesCalcanectomy

Keywords

CalcanectomyEq5d5l

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    12 months post-surgery

Secondary Outcomes (7)

  • Time to Wound Healing

    1, 3, 6, and 12 months post-surgery

  • Quality of life measured with the EQ5D5L (Health Questionnaire)

    1 month post-surgery

  • Quality of life measured with the EQ5D5L (Health Questionnaire)

    3 months post-surgery

  • Quality of life measured with the EQ5D5L (Health Questionnaire)

    6 months post-surgery

  • Quality of life measured with the EQ5D5L (Health Questionnaire)

    12 months post-surgery

  • +2 more secondary outcomes

Study Arms (2)

Partial Calcanectomy with Cerament G

EXPERIMENTAL

Patients will undergo partial calcanectomy with the application of Cerament G.

Device: Cerament G

Standard Partial Calcanectomy

ACTIVE COMPARATOR

Patients will undergo partial calcanectomy with standard antibiotic therapy.

Other: Standard Surgical Managment

Interventions

Cerament GDEVICE

Partial Calcanectomy plus cerament G

Partial Calcanectomy with Cerament G
Standard Surgical ManagmentOTHER

Partial Calcanectomy as standard of care

Standard Partial Calcanectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and over
  • Undergoing partial calcanectomy
  • Patients with Type1 or Type 2 Diabetes
  • Patients will be stratified by Pulse status and eGFR

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Galway

Galway, Ireland

Location

MeSH Terms

Conditions

OsteomyelitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Bone Diseases, InfectiousInfectionsBone DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • James Walsh

    Beaumont Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Walsh

CONTACT

+353 1 809 3344james@walshortho.ie

Ramy Elkady

CONTACT

drramyelkady86@hotmail.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 10, 2025

Study Start

July 25, 2025

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

July 25, 2026

Last Updated

August 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)