Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection

NCT01951768 | Completed Phase 4 Results

• 1 other identifier: HUG protocol
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Clinical Cure

  Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection

  Approximately day 38

Secondary Outcomes (2)

• Clinical Response

  up to 38 days

• Pathogen Eradication

  up to 38 days

Study Arms (2)

Garamycin Sponge (Gentamicin-Collagen Sponge)

EXPERIMENTAL

Garamycin Sponge (Gentamicin-Collagen sponge) applied daily plus systemic antibiotic and standard ulcer care

Drug: Garamycin Sponge (Gentamicin-Collagen sponge)

Systemic Antibiotic

ACTIVE COMPARATOR

Systemic antibiotic therapy and standard ulcer care

Drug: Systemic Antibiotic

Interventions

Garamycin Sponge (Gentamicin-Collagen sponge) DRUG

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)

Also known as: Sponge arm

Garamycin Sponge (Gentamicin-Collagen Sponge)

Systemic Antibiotic DRUG

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

Also known as: Control arm

Systemic Antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 30068306 BACKGROUND

• 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.

  PMID: 29785265 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Dr. med. Ilker Uçkay
• Organization: Geneva University Hospitals, Balgrist University Hospital

ilker.uckay@balgrist.ch

+41 44 386 11 11

Study Officials

• Ilker Uçkay

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Service of Infectious Diseases, Consultant for Septic Orthopaedics

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 27, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 4, 2019
• Results First Posted: November 4, 2019

Record last verified: 2019-11

Locations

CH (1)