Diabetic Foot UlcerPhase 3STRIDE 5NCT01840085
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
A Phase 3 study testing 0.03% DSC127 topical gel in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation at 21 sites in United States.
Trial summary
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- 0.03% DSC127 topical gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ambulatory subjects who are at least 18 years of age at screening
- Have at least one ulcer:
- chronic ( present >1month)
- Wagner Grade 1 or Grade 2 ulcer (i.e. Partial- or full- thickness and not involving bone, tendon or capsule (probing to tendon or capsule) and/or penetrating to tendon or capsule.)
- with no sign of infection or osteomyelitis, and
- is located below the malleolus.
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- Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential.
- Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to study enrollment.
- Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period.
- Female subjects of child-bearing potential must be willing to use a medically acceptable method of birth control, such as Essure®, hormonal contraception (oral pills, implantable device or skin patch), intrauterine device, tubal ligation, double barrier, or abstinence during the treatment periods of study participation.
- Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
Who cannot join
- Has a known hypersensitivity to any of the study medication components.
- Exposure to any investigational product within 30 days of entry into study.
- Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years.
- Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than the upper level of normal on two occasions.
- Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G)
- Receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy.
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- Prior radiation therapy of the foot with the ulcer under study.
- Current use of systemic corticosteroids or immunosuppressants within 8 weeks prior to enrollment into the study
- Sickle-cell anemia, Raynaud's or other peripheral vascular disease.
- Subjects receiving a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the 7 days prior to exposure to DSC127.
- Subject who, in the opinion of the investigator, has uncontrolled hypertension
- Subject has an ulcer which is determined to be clinically infected and requires antimicrobials or agents known to affect wound healing or has been taking systemic antibiotics for more than 7 days for any reason. (Subjects with infection at the initial visit of the Screening Period can be re-screened three weeks later after a single course of antibiotic therapy (occurring concurrently - within three weeks of the initial visit, the antibiotic treatment must have completed and some washout (7 days) must have elapsed); if after that time infection is still present, the subject will be excluded.)
- Subjects who, in the opinion of the investigator, have clinically significant anemia
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Carolina Musculoskeletal Institute
Aiken, South Carolina, 29801
Reliance Institute of Clinical Research
Chino, California, 91710
Roy O. Kroeker, DMP, Inc.
Fresno, California, 93710
Limb Preservation Platform (LPP)
Fresno, California, 93720
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834
Advanced Research Institute of Miami
Homestead, Florida, 33030
UF Health Orthopaedic Surgery Clinic
Jacksonville, Florida, 32209
Foot and Ankle Clinic
Los Angeles, California, 90010
Phoenix Medical Research, LLC
Miami, Florida, 33165
Miami Dade Medical Research Institute
Miami, Florida, 33176
GF Professional Research
Miami Lakes, Florida, 33016
WILMAX Clinical Research
Mobile, Alabama, 36608
Barry University Clinical Research
North Miami Beach, Florida, 33169
Professional Education and Research Institute
Roanoke, Virginia, 24016
Endeavor Clinical Trials
San Antonio, Texas, 78229
Center for Clinical Research, Inc.
San Francisco, California, 94115
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713
Olive View - UCLA Medical Center
Sylmar, California, 91342
Orange County Research Center
Tustin, California, 92780
O'Malley Foot and Ankle
Wilmington, North Carolina, 28411
Martin Foot & Ankle
York, Pennsylvania, 17402
About this study
Official title: Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
Read the detailed description
All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first.
If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria.
For the entire duration of each treatment period the standard of care for DFU will be maintained.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- 0.03% DSC127 topical gel
- Keywords
- Diabetic foot ulcer, plantar neuropathic ulcer, plantar neuroischemic ulcer, Wagner Grade 1 or Grade 2 DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.03% DSC127 topical gelDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.03% DSC127 topical gel | Experimental | Not described Receives: Drug: 0.03% DSC127 topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment
Measured: 2.5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startDec 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- John Caminis, MD, Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840085
- Sponsor's protocol ID
- DSC127-2012-05
- Acronym
- STRIDE 5
- Status last verified
- Dec 2017
- First submitted
- 23 Apr 2013
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase III Clinical Trial to Evaluate the Safety of 0.03% DSC127 Gel in Chronic Use for Treating Diabetic Foot Ulcers ("DFU")
- ClinicalTrials.gov ID
- NCT01840085
- Acronym / sponsor ID
- STRIDE 5 / DSC127-2012-05
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, plantar neuropathic ulcer, plantar neuroischemic ulcer, Wagner Grade 1 or Grade 2 DFU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Dec 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of topical 0.03% DSC127 Gel when used for one or more continuous treatment periods on a chronic Wagner Grade 1 or 2 foot ulcer(target ulcer) or multiple ulcers in diabetic subjects. The maximum duration of any treatment period is 24 weeks.
Detailed description
All eligible subjects enrolled will begin daily Treatment with topical 0.03% DSC127 gel until complete wound closure (defined as skin re-epithelialization without drainage or dressing requirement) or 24 weeks, whichever occurs first.
If a patient has multiple ulcers on one foot, all may be treated, within the maximum of 24 weeks. If the ulcer does not heal, after a wash out period of 1 week, a new treatment period of up to 24 weeks may be initiated. Ulcer may be retreated if it recurs or if a new ulcer develops that meets study criteria.
For the entire duration of each treatment period the standard of care for DFU will be maintained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.03% DSC127 topical gel | Experimental | Drug: 0.03% DSC127 topical gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ambulatory subjects who are at least 18 years of age at screening
- Have at least one ulcer:
- Have an ABI > 0.7, or have a TcPO2 > 40 mm Hg or great toe systolic pressure > 50 mmHg to ensure healing potential.
- Have Type I or Type II diabetes under metabolic control as confirmed by glycosylated hemoglobin (HbA1c) of ≤ 14%, obtained at enrollment or within 30 days prior to study enrollment.
- Female subjects of child-bearing potential must have a negative pregnancy test at the time of enrollment and at the initiation of each study treatment period.
Key exclusion criteria (13 listed)
- Has a known hypersensitivity to any of the study medication components.
- Exposure to any investigational product within 30 days of entry into study.
- Has active malignant disease of any kind (with the exception of basal cell carcinoma). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. Disease-free is defined as in remission for at least 5 years.
- Chronic liver dysfunction evidenced by transaminase levels > 2.5 times higher than the upper level of normal on two occasions.
- Has a history of additional risk factors for TdP (eg. heart failure, hypokalemia, family history of Long QT Syndrome) or taking medication which are known to prolong QT/QTc (Appendix G)
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 |
|---|---|---|
| 0.03% DSC127 topical gel | Drug | 0.03% DSC127 topical gel |
Primary outcome
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment
Time frame: 2.5yrs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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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.
John Caminis, MD study director
Integra LifeSciences Corporation
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.03% DSC127 topical gel in people with Diabetic Foot Ulcer, run by Integra LifeSciences Corporation at 21 sites 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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
The proportion of all subjects reporting Adverse Events and Serious Adverse Events related to study treatment (time frame: 2.5yrs). 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 12 Dec 2017.