Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
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| ClinicalTrials.gov Identifier: NCT01951768 |
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Recruitment Status :
Completed
First Posted : September 27, 2013
Results First Posted : November 4, 2019
Last Update Posted : November 4, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Foot Ulcer | Drug: Garamycin Sponge (Gentamicin-Collagen sponge) Drug: Systemic Antibiotic | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | June 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Garamycin Sponge (Gentamicin-Collagen Sponge)
Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care
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Drug: Garamycin Sponge (Gentamicin-Collagen sponge)
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)
Other Name: Sponge arm |
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Active Comparator: Systemic Antibiotic
Systemic antibiotic therapy and standard ulcer care
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Drug: Systemic Antibiotic
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 Other Name: Control arm |
- Clinical Cure [ Time Frame: Approximately day 38 ]Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection
- Clinical Response [ Time Frame: up to 38 days ]Clinical significant improvement is defined as significant improvement of infection but not complete cure (e.g., residual uninfected skin lesions).
- Pathogen Eradication [ Time Frame: up to 38 days ]Microbiological eradication of former infection
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951768
| Switzerland | |
| Geneva University Hospitals | |
| Geneva, Switzerland | |
| Principal Investigator: | Ilker Uçkay | University Hospital, Geneva |
| Responsible Party: | Ilker Uckay, Consultant Service of Infectious Diseases, Consultant for Septic Orthopaedics, University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT01951768 |
| Other Study ID Numbers: |
HUG protocol |
| First Posted: | September 27, 2013 Key Record Dates |
| Results First Posted: | November 4, 2019 |
| Last Update Posted: | November 4, 2019 |
| Last Verified: | November 2019 |
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Diabetic Foot Foot Ulcer Ulcer Pathologic Processes Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases Diabetes Complications |
Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies Foot Diseases Anti-Bacterial Agents Gentamicins Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |