The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers

Browse trials for

• Diabetic Foot 1,054
• Foot Ulcer 691
• Ulcer 2,021

Keywords

• Diabetes
• ulcers
• ulcerations
• infection

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Lead sponsor

Innocoll is the lead sponsor of 21 studies on the registry; none are open to participants now.

Study arms

• Experimental
  A

  Gentamicin sponge applied into wound plus levofloxacin, 750 mg by mouth (po) or intravenous (IV) every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing

  Drug: gentamicin-collagen sponge and levofloxacin

• Active comparator
  B

  Levofloxacin, 750 mg po or IV every 24 hours or, if ulcer culture results show resistance to levofloxacin, alternative antimicrobial therapy as determined by susceptibility testing

  Drug: Levofloxacin only

Interventions

• Druggentamicin-collagen sponge and levofloxacin

  Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.

  Also known as: Collatamp G

• DrugLevofloxacin only

  levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours

  Also known as: Tavanic, Levaquin

Primary outcomes

1. Number of Participants With a Clinical Cure at Visit 3 (Day 7)

   Number of participants with a clinical cure in each treatment group at Visit 3 (Day 7). Clinical Cure is defined as positive clinical response and with pathogen eradication.

   Time frame: Day 7 of treatment

Secondary outcomes

1. Number of Participants With a Positive Clinical Response at Each Time Point

   Number of patients with positive clinical response, defined as those with a clinical outcome of "clinical cure" or "clinical improvement" in each treatment group at/by each time point

   Time frame: Day 3, 7, 10,14, 21, 28 and 42

2. Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)

   clinical cure is defined as having a positive clinical response and with pathogen eradication

   Time frame: Day 3, 10, 14, 21, 28 & 42

3. Number of Participants With Pathogen Eradication by Visit

   Time frame: Day 3, 7, 10, 14, 21 & 28

4. Change From Baseline in Total Wound Surface Area Measured in cm^2

   Wound Surface Area was measured in cm² Actual Values Total wound surface area was compared across treatments using 2-sample t-tests. Wound tracings were obtained at study visits by trained study personnel who were blinded to the patient data and regimen. A centralized imaging facility provided both wound perimeter and area measurements.

   Time frame: Day 3, 7, 10, 14, 21, 28 & 42

5. Time to Clinical Cure

   clinical cure is defined as having a positive clinical response and with pathogen eradication

   Time frame: Days 1 through 49

6. Visual Analog Scale (VAS) for Pain Assessment

   Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is "0" and the maximum score is 100\* the number of hours in that period.

   Time frame: Day 3, 7, 10, 14, 21, 28 & 42

7. Lipsky Wound Score

   The Lipsky wound scoring scale consists of scoring categories for purulent drainage, non-purulent drainage, erythema, induration, tenderness, pain, local warmth and wound measurements. This wound scoring system allows us to take the size and depth of the wound into consideration as well as all signs and symptoms of inflammation and infection. A quantitative score that assess wounds both at baseline and during therapy to compare wound scores over time. The higher the score the worse the inflammation and/or infection is. The Lowest score possible is "3" and the highest score possible is "64".

   Time frame: Days 3, 7, 10, 14, 21, 28, 42

Baseline characteristics

Publications

• Lipsky BA, Kuss M, Edmonds M, Reyzelman A, Sigal F. Topical application of a gentamicin-collagen sponge combined with systemic antibiotic therapy for the treatment of diabetic foot infections of moderate severity: a randomized, controlled, multicenter clinical trial. J Am Podiatr Med Assoc. 2012 May-Jun;102(3):223-32. doi: 10.7547/1020223. Erratum In: J Am Podiatr Med Assoc. 2012 Jul-Aug;102(4):323. PubMed 22659765 ↗