Clinical trial NCT01951768: Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot Ulcer
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Cure
timeFrame: Approximately day 38
Secondary outcomes:
measure: Clinical Response
timeFrame: up to 38 days
measure: Pathogen Eradication
timeFrame: up to 38 days
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Ilker Uçkay
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Uckay 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.