Diabetic Foot UlcerPhase 4NCT01951768
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
A Phase 4 study testing Garamycin Sponge (Gentamicin-Collagen sponge) and Systemic Antibiotic in people with Diabetic Foot Ulcer, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Garamycin Sponge (Gentamicin-Collagen sponge) and Systemic Antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Is aged ≥ 18.
- Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
- Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA).
- Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis
- Meets certain minimal laboratory criteria.
Who cannot join
- Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol.
- Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled.
- Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
Read the detailed description
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation.
Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin sponge being used in this study is commercially available in Switzerland as Garamycin® Sponge. The Garamycin Sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.
All subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic. Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Garamycin Sponge (Gentamicin-Collagen sponge), Systemic Antibiotic
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garamycin Sponge (Gentamicin-Collagen sponge)Drug
Also called Sponge arm
Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)
Systemic AntibioticDrug
Also called Control arm
Antibiotics options per protocol:
Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h
| Study group | Role | What they receive |
|---|---|---|
| Garamycin Sponge (Gentamicin-Collagen Sponge) | Experimental | Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care Receives: Drug: Garamycin Sponge (Gentamicin-Collagen sponge) |
| Systemic Antibiotic | Active comparator | Systemic antibiotic therapy and standard ulcer care Receives: Drug: Systemic Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection
Measured: Approximately day 38
Secondary outcomes (2)
Clinical Response
Clinical significant improvement is defined as significant improvement of infection but not complete cure (e.g., residual uninfected skin lesions).
Measured: up to 38 days
Pathogen Eradication
Microbiological eradication of former infection
Measured: up to 38 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Uckay, University Hospital, Geneva
- Investigators
- Ilker Uçkay, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951768
- Sponsor's protocol ID
- HUG protocol
- Status last verified
- Nov 2019
- First submitted
- 18 Sep 2013
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Uckay I, Kressmann B, Malacarne S, Toumanova A, Jaafar J, Lew D, Lipsky BA. A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection. BMC Infect Dis. 2018 Aug 2;18(1):361. doi: 10.1186/s12879-018-3253-z.
PubMed 30068306Uckay I, Kressmann B, Di Tommaso S, Portela M, Alwan H, Vuagnat H, Maitre S, Paoli C, Lipsky BA. A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE Open Med. 2018 May 13;6:2050312118773950. doi: 10.1177/2050312118773950. eCollection 2018.
PubMed 29785265
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
- ClinicalTrials.gov ID
- NCT01951768
- Acronym / sponsor ID
- HUG protocol
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Sep 2013 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Garamycin Sponge (Gentamicin-Collagen sponge) in combination with antibiotics is safe and effective in treating moderate and severe diabetic foot infections.
Detailed description
Infected skin ulcers with diabetes can be very debilitating because they are difficult to heal. Diabetic ulcers are responsible for frequent health care visits, and are a major predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain or warmth as well as peripheral vascular disease, which causes diminished blood flow to the foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the need for amputation.
Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin sponge being used in this study is commercially available in Switzerland as Garamycin® Sponge. The Garamycin Sponge is a thin flat sponge made out of collagen that comes from bovine tendons and containing gentamicin. When applied to an open ulcer, the collagen breaks down and the gentamicin is released into the ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in the open infected ulcer may help treat the infection.
All subjects will be given the necessary supplies and taught how to take care their foot ulcer. All subjects will also receive oral an antibiotic. Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge will place a gentamicin-collagen sponge on their ulcer during daily wound care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garamycin Sponge (Gentamicin-Collagen Sponge) | Experimental | Drug: Garamycin Sponge (Gentamicin-Collagen sponge)Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care |
| Systemic Antibiotic | Active comparator | Drug: Systemic AntibioticSystemic antibiotic therapy and standard ulcer care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is aged ≥ 18.
- Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria.
- Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA).
- Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis
- Meets certain minimal laboratory criteria.
Key exclusion criteria (3 listed)
- Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol.
- Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled.
- Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garamycin Sponge (Gentamicin-Collagen sponge)Also: Sponge armGentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) | Drug | Garamycin Sponge (Gentamicin-Collagen Sponge) |
| Systemic AntibioticAlso: Control armAntibiotics options per protocol: Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h | Drug | Systemic Antibiotic |
Primary outcome
Clinical Cure
Time frame: Approximately day 38
Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection
2 secondary outcomes
Clinical Response
Time frame: up to 38 days
Pathogen Eradication
Time frame: up to 38 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30068306Uckay I, Kressmann B, Malacarne S, Toumanova A, Jaafar J, Lew D, Lipsky BA. A randomized, controlled study to investigate the efficacy and safety of a topical gentamicin-collagen sponge in combination with systemic antibiotic therapy in diabetic patients with a moderate or severe foot ulcer infection. BMC Infect Dis. 2018 Aug 2;18(1):361. doi: 10.1186/s12879-018-3253-z.
- Background: PubMed 29785265Uckay I, Kressmann B, Di Tommaso S, Portela M, Alwan H, Vuagnat H, Maitre S, Paoli C, Lipsky BA. A randomized controlled trial of the safety and efficacy of a topical gentamicin-collagen sponge in diabetic patients with a mild foot ulcer infection. SAGE Open Med. 2018 May 13;6:2050312118773950. doi: 10.1177/2050312118773950. eCollection 2018.
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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.
Ilker Uçkay principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Garamycin Sponge (Gentamicin-Collagen sponge) and Systemic Antibiotic in people with Diabetic Foot Ulcer, run by University Hospital, Geneva at 1 site in Switzerland.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: Approximately day 38). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01951768, which also lists 2 linked publications.
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 4 Nov 2019.