Diabetic Foot UlcerPRESERVENCT05316298
Diabetic Foot Osteomyelitis Treatment Using Gentamicin-loaded Calcium Sulfate-hydroxyapatite Biocomposite
An observational study of Diabetic Foot Ulcer and Osteomyelitis, run by University Medical Center Groningen at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Osteomyelitis, Diabetes Mellitus
- How many people
- 182 participants
- Where
- 10 sitesNetherlands
- Study dates
- 1 Dec 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, patients will be included who present in one of the 10 participating Dutch hospitals with forefoot diabetic foot ulcers complicated by osteomyelitis and sufficient skin and soft tissues around the ulcer for surgical closure.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites, 10 recruiting
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch
Bart Verhoeven, M.D.
- Recruiting
Hospitalgroup Twente
Almelo
Wouter ten Cate, M.D.
- Recruiting
Rijnstate Hospital
Arnhem
Luuk Smeets, M.D.
- Recruiting
Reinier de Graaf Hospital
Delft
Casper Smit, M.D.
- Recruiting
Slingeland Hospital
Doetinchem
Dick Scharn, M.D.
- Recruiting
St. Jansdal Hospital
Harderwijk
Vincent Scholtes, M.D.
- Recruiting
St. Antonius Hospital
Nieuwegein
Olaf Bakker, M.D.
- Recruiting
Franciscus Gasthuis & Vlietland
Rotterdam
Gijs Welten, M.D.
- Recruiting
Maasstad Hospital
Rotterdam
George Akkersdijk
- Recruiting
University Medical Center Utrecht
Utrecht
Bart-Jeroen Petri, M.D.
About this study
Official title: Gentamicin-loaded Calcium Sulfate-hydroxyaPatite Biocomposite to tREat Diabetic Foot Ulcers Complicated by oSteomyElitis: a pRospectiVE Cohort Study
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.
- Conditions
- Diabetic Foot Ulcer, Osteomyelitis, Diabetes Mellitus
- Keywords
- Surgical treatment, antibiotic-loaded bone graft substitute, Cerament G
- Medical subject headings
- Diabetic Foot, Osteomyelitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PRESERVE protocol | Treatment according to the PRESERVE protocol consists of 2 study phases. Phase 1 consists of standard-of-care non-surgical treatment, performed in accordance with current treatment guidelines, during which the research team performs observations. After failed standard-of care non surgical treatment, subjects will be included in study phase 2 and undergo 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 postoperative treatment regimen including woundcare, 10 days of antibiotics and offloading. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative wound healing
Macroscopic complete epithelialization of all surgical wounds after removal of sutures and/or staples without drainage for a minimum of 2 weeks.
Measured: 20 weeks
Secondary outcomes (4)
Duration to postoperative wound healing
Duration to postoperative wound healing, expressed in days postoperatively.
Measured: 20 weeks
persistent osteomyelitis postoperatively
The proportion of subjects without postoperative wound healing and with persistent osteomyelitis, diagnosis based on clinical findings (signs of inflammation) in combination with suggestive findings of osteomyelitis on imaging (X-ray, MRI) or a positive probe-to-bone test.
Measured: 20 weeks
Amputations during follow-up
Proportion of patients undergoing amputations (minor = distal to the ankle joint, major = proximal to the ankle joint)
Measured: 20 weeks
Foot Function Index (FFI) scores
Pre-operatively and at final follow-up, subjects will fill-in FFI-5pt questionnaires. These consist of 15 questions regarding pain in the foot and functional problems due to foot problems. These are translated in Dutch and have previously been validated. We will calculate the overall FFI scores and those or the domains of 'pain' and 'disability'. Per patient, we will also calculate the changes in mean or median FFI-5pt scores overall and separately for the domains of 'pain' and 'disability', by subtracting the FFI-5pt score measured at final follow-up from the FFI-5pt score measured at inclusion.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or 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
- Responsible party
- Sponsor
- Investigators
- Kor H. Hutting, M.D., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316298
- Sponsor's protocol ID
- 202200240
- Acronym
- PRESERVE
- Status last verified
- Nov 2022
- First submitted
- 30 Mar 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study the data will be made publically available
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gentamicin-loaded Calcium Sulfate-hydroxyaPatite Biocomposite to tREat Diabetic Foot Ulcers Complicated by oSteomyElitis: a pRospectiVE Cohort Study
- ClinicalTrials.gov ID
- NCT05316298
- Acronym / sponsor ID
- PRESERVE / 202200240
- Conditions
- Diabetic Foot Ulcer, Osteomyelitis, Diabetes Mellitus
- Keywords
- Surgical treatment, antibiotic-loaded bone graft substitute, Cerament G
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or 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
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRESERVE protocol | – | –Treatment according to the PRESERVE protocol consists of 2 study phases. Phase 1 consists of standard-of-care non-surgical treatment, performed in accordance with current treatment guidelines, during which the research team performs observations. After failed standard-of care non surgical treatment, subjects will be included in study phase 2 and undergo 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 postoperative treatment regimen including woundcare, 10 days of antibiotics and offloading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, patients will be included who present in one of the 10 participating Dutch hospitals with forefoot diabetic foot ulcers complicated by osteomyelitis and sufficient skin and soft tissues around the ulcer for surgical closure.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative wound healing
Time frame: 20 weeks
Macroscopic complete epithelialization of all surgical wounds after removal of sutures and/or staples without drainage for a minimum of 2 weeks.
4 secondary outcomes
Duration to postoperative wound healing
Time frame: 20 weeks
persistent osteomyelitis postoperatively
Time frame: 20 weeks
Amputations during follow-up
Time frame: 20 weeks
Foot Function Index (FFI) scores
Time frame: 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Yes. After completion of the study the data will be made publically available
Related trials for Diabetic Foot Ulcer
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kor H. Hutting, M.D. principal investigator
University Medical Center Groningen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer and Osteomyelitis, run by University Medical Center Groningen at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kor H. Hutting, M.D. (0031887084232, k.h.hutting@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative wound healing (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.