Status:
UNKNOWN
Diabetic Foot Osteomyelitis Treatment Using Gentamicin-loaded Calcium Sulfate-hydroxyapatite Biocomposite
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Ziekenhuisgroep Twente
Slingeland Hospital
Conditions:
Diabetic Foot Ulcer
Osteomyelitis
Eligibility:
All Genders
18+ years
Brief Summary
The amputation risk is high when diabetic foot ulcers, complicated by osteomyelitis, fail to heal after non-surgical standard-of-care treatment. A new treatment regimen has been developed recently and...
Eligibility Criteria
Inclusion
- 18 years of age or older.
- One or multiple forefoot diabetic foot ulcers complicated by osteomyelitis. The treating physician will diagnose osteomyelitis, based on either positive culture results or histopathologic findings of a bone sample, or on the combination of clinical findings of inflammation and a positive probe-to-bone test or imaging findings (X-ray, MRI) A patient with multiple forefoot DFOs can be included as long as all ulcers are related to osteomyelitis on one location.
- Sufficient soft tissues and skin for primary closure or closure by local tissue transposition after surgical debridement, as judged by the treating physician.
- Written declaration of informed consent
Exclusion
- Acute Charcot neuroarthropathy, which will be diagnosed by the treating physician based on clinical examination and MRI.
- Adequate surgical debridement is possible by performing an amputation, as judged clinically by the treating physician (e.g. DFO on the 4th or 5th digit).
- Contra-indications for the use of gentamicin-loaded calcium sulfate-hydroxyapatite biocomposite, as mentioned by the producer: hypersensitivity to any aminoglycoside antibiotics, myasthenia gravis, severe renal impairment, pre-existing calcium metabolism disorders, pregnancy, and breastfeeding. This information will be investigated using the patient's electronic health record file and verbal verification. Severe renal impairment is defined as chronic kidney disease with an estimated glomerular filtration rate \<30 ml/min/1.73m2 or renal replacement therapy.
- Foot deformities that lead to increased pressure and friction on the site of the ulcer, which can only be adequately managed by surgical correction, as judged clinically by the treating physician.
- Implants in bone affected by osteomyelitis
- Inadequate quality and / or volume of soft tissues and skin for primary closure or closure by local tissue transposition after surgical debridement, as judged by the treating physician.
- No written declaration of informed consent.
- Osteomyelitis on ≥1 separate locations.
- Other infected diabetic foot ulcers.
- Severe chronic limb Ischemia, defined in accordance with the Wound-, Ischemia-, Foot Infection classification as signs and / or symptoms of peripheral artery disease and a systolic toe pressure \< 30 mmHg and/or a transcutaneous oxygen pressure \< 30 mmHg in the forefoot.Previous revascularisation is no exclusion criterion.
- Severe communication disabilities as judged by the treating physician, which would interfere with adherence to instructions.
- Severe diabetic foot infection, defined as infection-grade 4 according to the International Working Group on the Diabetic Foot classification.
- Severely immunocompromised state as judged by the treating physician (e.g., neutropenia due to chemotherapy, high doses of corticosteroids, HIV infection with CD4 count \<200 / µl).
Key Trial Info
Start Date :
December 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05316298
Start Date
December 1 2022
End Date
January 1 2025
Last Update
November 16 2022
Active Locations (10)
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1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
2
Hospitalgroup Twente
Almelo, Netherlands
3
Rijnstate Hospital
Arnhem, Netherlands
4
Reinier de Graaf Hospital
Delft, Netherlands