Diabetic Foot UlcerPhase 2NCT00593567
Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With a Mild Infection of a Foot Ulcer
A Phase 2 study testing gentamicin-collagen sponge and Levofloxacin 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 of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to May 2009
- 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 to 80 years.
- Has diabetes mellitus, according to the American Diabetes Association criteria.
- Has a single infected skin ulcer below the knee, defined as "mild" by the Infectious Disease Society of America (IDSA) Guidelines, for whom, in the Investigator's judgment, topical or oral antimicrobial therapy is appropriate (Mild infection severity: The presence of ≥ 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth or induration) but any cellulitis/erythema extends ≤ 2 cm around the ulcer, and the infection is limited to the skin or superficial subcutaneous tissue, with no other local complications or acute, systemic illness).
- Has had an x-ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
- Meets the certain minimal laboratory criteria
- Has an ankle-brachial index (ABI) ≥ 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 ≥ 40 mm Hg on the limb with the target ulcer.)
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- If female, is nonpregnant (negative pregnancy tests 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 1 of the following medically-acceptable methods of birth control and agrees to continue with the regimen throughout the duration of the study:
- Oral, implantable or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit
- Total abstinence from sexual intercourse (≥ 1 complete menstrual cycle before the Baseline/Randomization Visit)
- Intrauterine device (IUD)
- Double barrier method (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
- 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 an infecting pathogen known to be intermediate or resistant in vitro to levofloxacin. Patients enrolled into the study presumptively will be discontinued if their cultured organism is intermediate or resistant to levofloxacin.
- Has a target ulcer with a wound size > 5 × 5 cm.
- Has gangrenous tissue of the affected limb that cannot be removed with a single debridement.
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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]).
- Has documented osteomyelitis.
- 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.
- Is undergoing dialysis (renal or peritoneal) or has 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.
United States1 site
Chesapeake Research Group LLC
Pasadena, Maryland, 21122
About this study
Official title: A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer
The purpose of this study is to determine whether the gentamicin-collagen sponge when combined with standard of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
Read the detailed description
Infected skin ulcers in patients 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 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 of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- gentamicin-collagen sponge, Levofloxacin
- Keywords
- Diabetic Foot Ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gentamicin-collagen spongeDrug
Inserted daily into open ulcer
LevofloxacinDrug
750mg oral levofloxacin daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Daily topical gentamicin sponge and standard daily wound care Receives: Drug: gentamicin-collagen sponge |
| B | Active comparator | Daily oral levofloxacin 750 mg and standard daily wound care Receives: Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Clinical Outcome of "Clinical Cure"
Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.
Measured: Final Study Visit (Day 21 [or 28 or 35])
Secondary outcomes (6)
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Number of participants with a clinical outcome of "clinical cure" in each treatment group at/by each time point (except the Final Study Visit). Clinical Cure is defined as positive clinical response and with pathogen eradication.
Measured: Each time point (Day 3, 7 [14 and 21 if necessary])
Time to Baseline Pathogen Eradication
Measured: assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported
Number of Participants With Complete Wound Closure by Each Visit
Measured: At each timepoint Day 3, 7, 14 & 21
Time to Clinical Cure
Time to Clinical Cure is measured by days to the first observed cure. Clinical Cure is defined as positive clinical response and with pathogen eradication.
Measured: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])
Time to Pathogen Eradication
Time to Baseline Pathogen Eradication summed
Measured: Actual time assessed (Day 1-21
Time to Positive Clinical Response
Measured: (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
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.
- 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
- 70 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
- NCT00593567
- Sponsor's protocol ID
- INN-TOP-001
- Status last verified
- May 2022
- First submitted
- 4 Jan 2008
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Safety and Efficacy of a Topical Gentamicin-Collagen Sponge Compared to Levofloxacin in Diabetic Patients With a Mild Infection of a Lower Extremity Skin Ulcer
- ClinicalTrials.gov ID
- NCT00593567
- Acronym / sponsor ID
- INN-TOP-001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 31 May 2022
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 of daily wound care is safe and effective in treating mildly infected skin ulcers compared to treatment with an oral antibiotic (levofloxacin) and standard daily wound care.
Detailed description
Infected skin ulcers in patients 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 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 of their foot ulcer. Subjects who are randomly assigned to the gentamicin-collagen sponge treatment group will place a gentamicin-collagen sponge on their ulcer during daily wound care. Subjects who are randomly assigned to the oral levofloxacin treatment group will also perform daily wound care, but they will not be given the gentamicin-collagen sponge. Instead they will be given the antibiotic, levofloxacin to take by mouth during the treatment period.
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 spongeDaily topical gentamicin sponge and standard daily wound care |
| B | Active comparator | Drug: LevofloxacinDaily oral levofloxacin 750 mg and standard daily wound care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is a man or woman aged 18 to 80 years.
- Has diabetes mellitus, according to the American Diabetes Association criteria.
- Has a single infected skin ulcer below the knee, defined as "mild" by the Infectious Disease Society of America (IDSA) Guidelines, for whom, in the Investigator's judgment, topical or oral antimicrobial therapy is appropriate (Mild infection severity: The presence of ≥ 2 manifestations of inflammation (purulence or erythema, pain, tenderness, warmth or induration) but any cellulitis/erythema extends ≤ 2 cm around the ulcer, and the infection is limited to the skin or superficial subcutaneous tissue, with no other local complications or acute, systemic illness).
- Has had an x-ray of the infected area within the 2 days immediately preceding or at Visit 1 (Baseline/Randomization) that is negative for osteomyelitis.
- Meets the certain minimal laboratory criteria
Key exclusion criteria (15 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 an infecting pathogen known to be intermediate or resistant in vitro to levofloxacin. Patients enrolled into the study presumptively will be discontinued if their cultured organism is intermediate or resistant to levofloxacin.
- Has a target ulcer with a wound size > 5 × 5 cm.
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 spongeInserted daily into open ulcer | Drug | A |
| Levofloxacin750mg oral levofloxacin daily | Drug | B |
Primary outcome
Number of Participants With a Clinical Outcome of "Clinical Cure"
Time frame: Final Study Visit (Day 21 [or 28 or 35])
Number of Participants with a clinical outcome of "clinical cure" at final visit. Clinical Cure is defined as positive clinical response and with pathogen eradication.
6 secondary outcomes
Number of Participants With a Clinical Outcome of "Clinical Cure" in Each Treatment Group
Time frame: Each time point (Day 3, 7 [14 and 21 if necessary])
Time to Baseline Pathogen Eradication
Time frame: assessed at each time point on days 7, 14, 21, time to pathogen eradication from baseline up to day 21 reported
Number of Participants With Complete Wound Closure by Each Visit
Time frame: At each timepoint Day 3, 7, 14 & 21
Time to Clinical Cure
Time frame: Actual time assessed (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])
Time to Pathogen Eradication
Time frame: Actual time assessed (Day 1-21
Time to Positive Clinical Response
Time frame: (Day 1, 3, 7 [14 and 21 if necessary] and Day 21 [or 28 or 35])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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 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 14 inclusion and 15 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 31 May 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 31 May 2022). 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 Outcome of "Clinical Cure" (time frame: Final Study Visit (Day 21 [or 28 or 35])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022.