Gentamicin-loaded Calcium Sulfate-hydroxyaPatite Biocomposite to tREat Diabetic Foot Ulcers Complicated by oSteomyElitis: a pRospectiVE Cohort Study
Acronym: PRESERVE
ClinicalTrials.gov ID: NCT05316298
Organization: University Medical Center Groningen
Status: UNKNOWN
Study type: OBSERVATIONAL
Conditions: Diabetic Foot Ulcer
Osteomyelitis
Diabetes Mellitus
Lead sponsor: University Medical Center Groningen (OTHER)
Collaborators: Ziekenhuisgroep Twente
Slingeland Hospital
Franciscus Gasthuis
UMC Utrecht
Rijnstate Hospital
Jeroen Bosch Ziekenhuis
Reinier de Graaf Groep
St. Antonius Hospital
St Jansdal Hospital
Maasstad Hospital
Enrollment: 182 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2022-12-01
Completion date: 2025-01-01
Locations:
facility: Jeroen Bosch Hospital
city: 's-Hertogenbosch
country: Netherlands
facility: Hospitalgroup Twente
city: Almelo
country: Netherlands
facility: Rijnstate Hospital
city: Arnhem
country: Netherlands
facility: Reinier de Graaf Hospital
city: Delft
country: Netherlands
facility: Slingeland Hospital
city: Doetinchem
country: Netherlands
facility: St. Jansdal Hospital
city: Harderwijk
country: Netherlands
facility: St. Antonius Hospital
city: Nieuwegein
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Rotterdam
country: Netherlands
facility: University Medical Center Utrecht
city: Utrecht
country: Netherlands

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 has been proven feasible. This treatment regimen consists of surgical debridement, followed by bone void filling with gentamicin-loaded calcium sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, in combination with antibiotic therapy and offloading. This treatment regimen has not been investigated prospectively.

Therefore, this multicenter prospective cohort study was designed, with the primary objective of investigating postoperative wound healing. Patients with diabetic forefoot ulcers, complicated by osteomyelitis, will be included. The most relevant exclusion criteria are: Severe diabetic foot infection, severe limb ischemia, and foot deformity causing high pressure and friction on the diabetic foot ulcer. After inclusion, subjects will undergo study phase 1, which is observation of the standard-of-care non-surgical treatment. When standard-of-care non-surgical treatment is unsuccessful, subjects will be included in study phase 2, which consists of treatment by surgical debridement of the diabetic foot ulcer and underlying osteomyelitis, followed by bone void filling with gentamicin-loaded calcium sulfate-hydroxyapatite biocomposite and closure of soft tissues and skin, followed by a postoperatieve treatment regimen which involves wound care, 10 days of antibiotic therapy and offloading.

The primary outcome measure of this study is the proportion of subjects with post-operative wound healing, which will be investigated clinically and will be objectified by a review panel of blinded, independent experts based on digital photographs. Follow-up will be performed until wound healing or for a maximum of 20 weeks. The primary outcome measure is the proportion of subjects with postoperative wound healing during 20 weeks of follow-up. Secondary outcome measures are: days until postoperative wound healing, proportion of subjects with persistent osteomyelitis post-operatively, proportion of subjects undergoing amputations during follow-up, foot function index scores at inclusion and after 20 weeks follow-up.