Diabetic Foot UlcersPhase 3STRIDE 1NCT01830348
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
A Phase 3 study testing DSC127 in people with Diabetic Foot Ulcers, run by Integra LifeSciences Corporation at 25 sites in United States.
Trial summary
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- DSC127
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 25 sitesUnited States
- Study dates
- Feb 2013to 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 subject age ≥18 years at the time of informed consent
- Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL
- At Screening and at Baseline (prior to randomization), subject has at least one ulcer that fulfills all of the following criteria:
- Present for ≥1 month and ≤1 year
- Partial- or full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule), i.e. Wagner Grade 1 or 2
- Has no sign of infection or osteomyelitis
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- Plantar neuropathic ulcer; ulcer must be predominantly on the plantar surface of the foot to ensure adequate off-loading and may include the toes
- Size of the target ulcer must be 0.75 - 6 cm2
- Target ulcer must be non-healing as defined as <30% reduction in size in response to standard of care during the two week Screening Period
- If more than one ulcer is present that meets the inclusion criteria, the largest one will be considered the Target ulcer.
- If there are two ulcers of the same size that meet all criteria, the one with the higher Wagner Grade will be considered the Target ulcer.
- If there are two ulcers of the same size and the same Wagner Grade, the one present for the longest qualifying time will be the Target ulcer.
- Has an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
- Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.
- A female subject of childbearing potential must have a negative serum pregnancy test at the time of Screening, and 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, or double barrier throughout the study. A female subject of childbearing potential who practices abstinence is not required to employ birth control.
- Has the 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 investigational drug or vehicle components
- Has been exposed to any investigational agent within 30 days of entry into the study
- A female who is pregnant or nursing
- Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- Has a hemoglobin of less than 8.5 gm/dL.
- Transaminase levels greater than 3 × normal
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- Is receiving hemodialysis or chronic ambulatory peritoneal dialysis (CAPD) therapy
- Has had prior radiation therapy of any part of the foot with the target ulcer under study
- Use of systemic corticosteroids and immunosuppressants (within the 8 weeks prior to screening)
- Has an ulcer primarily ischemic in etiology
- Has sickle-cell anemia, Reynaud's, or other peripheral vascular disease
- Has received a biologic agent, growth factors or skin equivalents (Regranex®, Apligraft, or Dermagraft), in the past 30 days
- Has a target ulcer which is determined to be clinically infected and requires antimicrobials. Any antibiotic therapy must be completed or discontinued at screening.
- Has a Wagner Grade 3 or greater DFU, deep abscess, or gangrene
- Has uncontrolled hypertension, in the opinion of the Investigator.
- Any other finding, which in the opinion of the Investigator, may interfere with the assessment of the product or participation of the subject in the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Carolina Musculoskeletel Institute
Aiken, South Carolina, 29801
Boston University Medical Center
Boston, Massachusetts, 02118
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Dallas VA Medical Center
Dallas, Texas, 75216
Clinical Research Center
Eugene, Oregon, 97401
Center for Clinical Research
Fair Oaks, California, 95628
Fort Worth Diagnostic Clinic
Fort Worth, Texas, 76104
Roy O Kroeker, DPM, Inc
Fresno, California, 93710
Memorial Medical Group
Granger, Indiana, 46530
East Carolina Foot and Ankle Specialists
Greenville, North Carolina, 27834
Advanced Research Institute of Miami
Homestead, Florida, 33030
UF Health Orthopaedic Surgery Clinic
Jacksonville, Florida, 32209
LaPorte Medical Group
La Porte, Indiana, 46350
Foot and Ankle Clinic
Los Angeles, California, 90010
Miami Dade Medical Research Institute
Miami, Florida, 33176
GF Professional Research
Miami Lakes, Florida, 33016
WILMAX Clinical Research Inc
Mobile, Alabama, 36680
Barry University Clinical Research
North Miami Beach, Florida, 33013
Brian O'Carroll, DPM, Inc.
Pismo Beach, California, 93449
Center for Clinical Research
Portland, Oregon, 97232
Professional Education and Research Institute
Roanoke, Virginia, 24016
Endeavor Clinical Trials
San Antonio, Texas, 78229
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713
UCLA Medical Center - Olive View
Sylmar, California, 91342
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Randomized, Double-blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.
Read the detailed description
Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization, providing they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.
All aspects of Standard of Care are followed throughout the study period.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- DSC127, placebo vehicle gel
- Keywords
- diabetic foot ulcers, Wagner Grade 1 or 2 foot ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSC127Drug
DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner
placebo vehicle gelDrug
| Study group | Role | What they receive |
|---|---|---|
| DSC127 | Active comparator | DSC127 0.03% in a vehicle gel (hydroxyethyl cellulose (HEC) with parabens) Receives: Drug: DSC127 |
| Vehicle gel | Placebo comparator | Vehicle gel comprising HEC with parabens Receives: Drug: placebo vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later).
Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.
Measured: Target ulcer must achieve complete wound closure by 10 weeks post first treatment
Secondary outcomes (1)
Time to the visit where the target ulcer achieves confirmed complete wound closure
Measured: Weekly assessments to ten weeks post first treatment dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startFeb 2013
- 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 UlcersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Gere S diZerega, MD, Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830348
- Sponsor's protocol ID
- DSC127-2012-01
- Acronym
- STRIDE 1
- Status last verified
- Dec 2017
- First submitted
- 15 Mar 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
- A Randomized, Double-blind, Parallel-group, Vehicle-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01830348
- Acronym / sponsor ID
- STRIDE 1 / DSC127-2012-01
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetic foot ulcers, Wagner Grade 1 or 2 foot ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 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.
The purpose of the study is to determine if DSC127 is effective in increasing incidence of complete wound closure at 10 weeks confirmed at a visit 2 weeks later when compared to the vehicle (gel without active ingredient) in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 plantar neuropathic foot ulcers, 0.75 - 6 cm2 in size.
Detailed description
Subjects will undergo a two week screening period to assess plantar ulcer healing, and those healing less than 30% will be eligible for randomization, providing they meet all other inclusion criteria. Four weeks of blinded "treatment" follows the screening period, and an observation period of six weeks (to 10 weeks post first treatment) follows the 4-week treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed two weeks later, and at this time the subject enters a durability assessment period of up to 12 weeks.
All aspects of Standard of Care are followed throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSC127 | Active comparator | Drug: DSC127DSC127 0.03% in a vehicle gel (hydroxyethyl cellulose (HEC) with parabens) |
| Vehicle gel | Placebo comparator | Drug: placebo vehicle gelVehicle gel comprising HEC with parabens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female ambulatory subject age ≥18 years at the time of informed consent
- Has type 1 or type 2 DM under metabolic control as confirmed by a glycosylated hemoglobin (HbA1c) of ≤12% and a serum creatinine level of ≤3mg/dL
- At Screening and at Baseline (prior to randomization), subject has at least one ulcer that fulfills all of the following criteria:
- Has an ankle brachial index (ABI) ≥ 0.7 on the foot with the target ulcer
- Has an assessment of the baseline level of neuropathy of the foot using Semmes-Weinstein filaments.
Key exclusion criteria (16 listed)
- Has a known hypersensitivity to any of the investigational drug or vehicle components
- Has been exposed to any investigational agent within 30 days of entry into the study
- A female who is pregnant or nursing
- Has active malignant disease of any kind except for basal cell carcinoma (of the skin). A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry.
- Has a hemoglobin of less than 8.5 gm/dL.
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 |
|---|---|---|
| DSC127DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner | Drug | DSC127 |
| placebo vehicle gel | Drug | Vehicle gel |
Primary outcome
The proportion of subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later).
Time frame: Target ulcer must achieve complete wound closure by 10 weeks post first treatment
Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated through tracings submitted to the Canfield system and photographs are collected as confirmation of closure via the Canfield system.
1 secondary outcome
Time to the visit where the target ulcer achieves confirmed complete wound closure
Time frame: Weekly assessments to ten weeks post first treatment dose
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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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Gere S diZerega, MD study director
Integra LifeSciences Corporation
25 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 DSC127 in people with Diabetic Foot Ulcers, run by Integra LifeSciences Corporation at 25 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 16 inclusion and 16 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 25 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. Some participants in this study may receive a placebo. 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 subjects with a target ulcer which achieves complete wound closure (skin re-epithelialization without drainage or dressing requirements) up to 10 weeks (confirmed at a study visit 2 weeks later). (time frame: Target ulcer must achieve complete wound closure by 10 weeks post first treatment). 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.