Diabetic Foot UlcerPhase 2NCT00659646
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
A Phase 2 study testing gentamicin-collagen sponge and levofloxacin and Levofloxacin only in people with Diabetic Foot Ulcer, run by Innocoll at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- gentamicin-collagen sponge and levofloxacin and Levofloxacin only
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Feb 2010
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a man or woman aged ≥ 18 and ≤ 80 years.
- Has diabetes mellitus, according to the American Diabetes Association criteria.
- Has a single infected skin ulcer below the knee, defined as "moderate" by the Infectious Disease Society of America (IDSA) Guidelines for whom, in the Investigator's opinion, intravenous (IV) or oral antimicrobial therapy is appropriate
- Has had an x ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis must receive appropriate surgical intervention to remove all necrotic and infected bone and otherwise meet enrollment criteria before being enrolled in the study.
- Meets certain minimal laboratory criteria
- Has an ankle brachial index (ABI) > or = 0.7 and ≤ 1.3. (Note: Patients with ABI < 0.7 or > 1.3 may be included if they have either a transcutaneous oxygen pressure or a toe pressure > or = 40 mm Hg on limb with ulcer.)
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- If female, is nonpregnant (negative pregnancy test results at the Baseline/Randomization Visit) and nonlactating.
- If female, is either not of childbearing potential (defined as postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or practicing a medically acceptable methods of birth control and agrees to continue with the regimen throughout the study
- Willing to return to the study facility for the Final Study Visit.
- Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Who cannot join
- Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or levofloxacin or drugs in the same class, or any of the test article or reference product components.
- Has a known hypersensitivity to bovine collagen.
- Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
- Has a target ulcer with a wound size > 10 × 10 cm.
- Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
- Has wound known to contain isolates resistant to levofloxacin.
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- Has a wound associated with prosthetic material or device.
- Received any topical or systemic antimicrobial therapy within the 2 weeks prior to study entry (Visit 1 [Day 1]).
- If severely immunocompromised, may be excluded at the discretion of the Investigator.
- Has a history of alcohol or substance abuse in the past 12 months.
- Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or peritoneal) or has a history of kidney transplant.
- Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the Investigator.
- Has a history of epilepsy
- Has a history of tendon disorders related to fluoroquinolone administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Open Label Study of the Safety and Efficacy of a Topical Gentamicin Collagen Sponge Combined With An Antibiotic Compared to Antibiotic Therapy Alone in Diabetic Patients With Moderately Infected Foot Ulcers
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).
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-collagen sponge is a thin flat sponge made out of collagen that comes from cow 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.
In this study, 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 (levofloxacin). 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
- gentamicin-collagen sponge and levofloxacin, Levofloxacin only
- Keywords
- Diabetes, ulcers, ulcerations, infection
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Ulcer, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicin-collagen sponge and levofloxacinDrug
Also called Collatamp G
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.
Levofloxacin onlyDrug
Also called Tavanic, Levaquin
levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 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 Receives: Drug: gentamicin-collagen sponge and levofloxacin |
| B | Active comparator | 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 Receives: Drug: Levofloxacin only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 7 of treatment
Secondary outcomes (7)
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
Measured: Day 3, 7, 10,14, 21, 28 and 42
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
Measured: Day 3, 10, 14, 21, 28 & 42
Number of Participants With Pathogen Eradication by Visit
Measured: Day 3, 7, 10, 14, 21 & 28
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.
Measured: Day 3, 7, 10, 14, 21, 28 & 42
Time to Clinical Cure
clinical cure is defined as having a positive clinical response and with pathogen eradication
Measured: Days 1 through 49
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.
Measured: Day 3, 7, 10, 14, 21, 28 & 42
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".
Measured: Days 3, 7, 10, 14, 21, 28, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionFeb 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- David Prior, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659646
- Sponsor's protocol ID
- INN-TOP-003
- Status last verified
- Jan 2022
- First submitted
- 11 Apr 2008
- Last updated
- 27 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 22659765
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open Label Study of the Safety and Efficacy of a Topical Gentamicin Collagen Sponge Combined With An Antibiotic Compared to Antibiotic Therapy Alone in Diabetic Patients With Moderately Infected Foot Ulcers
- ClinicalTrials.gov ID
- NCT00659646
- Acronym / sponsor ID
- INN-TOP-003
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes, ulcers, ulcerations, infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 30 Aug 2021
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 the gentamicin-collagen sponge when combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and effective in treating moderately infected skin ulcers compared to treatment only with standard daily wound care and an oral antibiotic (levofloxacin).
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-collagen sponge is a thin flat sponge made out of collagen that comes from cow 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.
In this study, 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 (levofloxacin). 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 |
|---|---|---|
| A | Experimental | Drug: gentamicin-collagen sponge and levofloxacinGentamicin 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 |
| B | Active comparator | Drug: Levofloxacin onlyLevofloxacin, 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is a man or woman aged ≥ 18 and ≤ 80 years.
- Has diabetes mellitus, according to the American Diabetes Association criteria.
- Has a single infected skin ulcer below the knee, defined as "moderate" by the Infectious Disease Society of America (IDSA) Guidelines for whom, in the Investigator's opinion, intravenous (IV) or oral antimicrobial therapy is appropriate
- Has had an x ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis must receive appropriate surgical intervention to remove all necrotic and infected bone and otherwise meet enrollment criteria before being enrolled in the study.
- Meets certain minimal laboratory criteria
Key exclusion criteria (14 listed)
- Has a known history of hypersensitivity to gentamicin (or other systemic aminoglycosides) or levofloxacin or drugs in the same class, or any of the test article or reference product components.
- Has a known hypersensitivity to bovine collagen.
- Has any uncontrolled illnesses that, in the opinion of the Investigator, would interfere with interpreting the results of the study.
- Has a target ulcer with a wound size > 10 × 10 cm.
- Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
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 |
|---|---|---|
| gentamicin-collagen sponge and levofloxacinAlso: Collatamp GTopical 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. | Drug | A |
| Levofloxacin onlyAlso: Tavanic, Levaquinlevofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours | Drug | B |
Primary outcome
Number of Participants With a Clinical Cure at Visit 3 (Day 7)
Time frame: Day 7 of treatment
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.
7 secondary outcomes
Number of Participants With a Positive Clinical Response at Each Time Point
Time frame: Day 3, 7, 10,14, 21, 28 and 42
Number of Participants With a Clinical Cure at Each Visit Except Visit 3 (Day 7)
Time frame: Day 3, 10, 14, 21, 28 & 42
Number of Participants With Pathogen Eradication by Visit
Time frame: Day 3, 7, 10, 14, 21 & 28
Change From Baseline in Total Wound Surface Area Measured in cm^2
Time frame: Day 3, 7, 10, 14, 21, 28 & 42
Time to Clinical Cure
Time frame: Days 1 through 49
Visual Analog Scale (VAS) for Pain Assessment
Time frame: Day 3, 7, 10, 14, 21, 28 & 42
Lipsky Wound Score
Time frame: Days 3, 7, 10, 14, 21, 28, 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22659765Lipsky 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.
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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.
David Prior study director
Innocoll
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gentamicin-collagen sponge and levofloxacin and Levofloxacin only in people with Diabetic Foot Ulcer, run by Innocoll at 1 site in United States.
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 10 inclusion and 14 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 27 Jan 2022. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Aug 2021). 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?
Number of Participants With a Clinical Cure at Visit 3 (Day 7) (time frame: Day 7 of treatment). 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 NCT00659646, which also lists 1 linked publication.
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 27 Jan 2022.