Diabetic Foot UlcersPhase 3STRIDE 2NCT01849965
Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers
A Phase 3 study testing DSC127 in people with Diabetic Foot Ulcers, run by Integra LifeSciences Corporation at 56 sites in 4 countries.
Trial summary
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2… 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
- 396 participants
- Where
- 56 sitesin 4 countries
- Study dates
- Apr 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 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 - predominately be on the plantar surface (i.e. weight bearing) 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 area in response to standard of care during the 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.
- Non-target ulcers will also be treated according to standard of care (Acute Charcot Neuroarthropathy of the foot with the target ulcer must be excluded)
- 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.
- A female subject of childbearing 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, 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 or standard of care gel 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 to 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 peripheral vascular disease
- Has received a biologic agent, growth factor, 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 higher 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 patient in the study.
Trial locations and contacts
56 sites in 4 countries.
56 sites in 4 countries
United States33 sites
Orthopedic Research Associates
Boynton Beach, Florida, 33472
Center for Clinical Research, Inc.
Castro Valley, California, 94546
Reliance Institute of Clinical Research
Chino, California, 91710
North Texas Podiatric Medicine & Surgery
Dallas, Texas, 75231
The Diabetic Foot and Wound Center
Denver, Colorado, 80220
Dr. Vincent Giacalone
Emerson, New Jersey, 07630
Vladimir Zeetser, DPM
Encino, California, 91316
Invesclinic, LLC
Fort Lauderdale, Florida, 33308
Bone and Joint Institute
Fort Worth, Texas, 76104
Wayne Memorial Hospital
Goldsboro, North Carolina, 27533
Research in Miami, Inc.
Hialeah, Florida, 33013
Houston Foot & Ankle Specialists
Houston, Texas, 77074
River City Clinical Research
Jacksonville, Florida, 32207
Regional Infectious Disease & Infusion Center Inc.
Lima, Ohio, 45801
Innovative Medical Technologies, LLC
Los Angeles, California, 90063
East Valley Foot and Ankle Specialist
Mesa, Arizona, 85206
Advanced Pharma CR, LLC
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
Phoenix Medical Research
Miami, Florida, 33165
New Phase Clincal Trials, Inc.
Miami Beach, Florida, 33140
Samuel Merritt University, California School of Podiatric Medicine
Oakland, California, 94609
Bluegrass Foot Center c/o Research Concierge, LLC
Owensboro, Kentucky, 42303
Paddington Testing Clinic
Philadelphia, Pennsylvania, 19103
Arizona Burn Center Maricopa Medical Center
Phoenix, Arizona, 85008
Associated Foot & Ankle Specialists, PC
Phoenix, Arizona, 85015
Ledesma Foot and Ankle
Phoenix, Arizona, 85032
Precision Trials
Phoenix, Arizona, 85032
Redwood Health Center
Salt Lake City, Utah, 84119
Center for Clinical Research, Inc.
San Francisco, California, 94115
Grace Research
Shreveport, Louisiana, 71101
American Center for Clinical Trials
Southfield, Michigan, 48034
O'Malley Foot and Ankle
Wilmington, North Carolina, 24801
Martin Foot & Ankle
York, Pennsylvania, 17403
South Africa14 sites
Worthwhile Clinical Trials
Benoni, Gauteng, 1500
Iatros International
Bloemfontein, Free State, 9301
Josha Research
Bloemfontein, Free State, 9301
Tiervlei Trial Centre, Karl Bremer Hospital
Cape Town, Western Cape, 7530
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, 4001
Flamco Clinical Trials
Durban, KwaZulu-Natal, 4092
Randles Road Medical Centre
Durban, ZwaZulu Natal, 4091
Dr Lakha's Consulting Rooms
Johannesburg, Gauteng, 1829
Newtown Clincal Research Centre
Newtown, Gauteng, 2113
Tread Research
Parow, Western Cape, 7505
Brookedale Clinical Research Centre
Phoenix, KwaZulu-Natal, 4068
GCT - Mercantile Clinical Trial Centre - Primecure Clinic
Port Elizabeth, Eastern Cape, 6020
Sunninghill Hospital
Sunninghill, Gauteng, 2157
Boland Ethical Research Group
Worcester, Western Cape, 6850
Canada5 sites
Centre Podiatrique et Soins des Plaies
Boucherville, Quebec, J4B 5E4
The Mayer Institute
Hamilton, Ontario, L8R 2R3
Lawson Health Research Institute
London, Ontario, N6C 5J1
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
Xceed Clinical
Whitby, Ontario, L1N 2L1
Puerto Rico4 sites
Centro de Curacion de Heridas del Caribe, Inc.
Aguadilla, 00603
Office of Renier D. Gonzalez-Cruz, MD
Juana Diaz, 00795
Clinical Research Puerto Rico
San Juan, 00909
Wound and Ulcer Care Clinic
San Juan, 00918
About this study
Official title: A Randomized, Double-Blind, Parallel-group, Vehicle and Standard of Care-controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DSC127 in Treating Non-healing Foot Ulcers in Subjects With Diabetes Mellitus
To determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 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 all other criteria are met. Four weeks of "blinded" randomized treatment follows the screening period, and an observation period of six weeks follows the treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed at a visit two weeks later, and at this time the subjects 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, Standard of Care gel, Aquasite
- Keywords
- diabetic foot ulcers, Wagner Grade 1 or 2 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 occurs sooner.
placebo vehicle gelDrug
Standard of Care gel, AquasiteDrug
| 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 |
| Standard of Care gel | Placebo comparator | Aquasite gel, as standard of care gel Receives: Drug: Standard of Care gel, Aquasite |
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 by 10 weeks (confirmed 2 weeks later) after initiation of treatment.
Primary endpoint of complete closure is assessed by the Principal Investigator at the site; ulcer measurements are calculated via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs vehicle control.
Measured: Target ulcer must achieve complete wound closure by 10 weeks post first treatment
Secondary outcomes (1)
The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed two weeks later) after initiation of treatment.
Primary endpoint of complete closure is assessed by the Principle Investigator at the site; ulcer measurements are calculated via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs Standard of Care control.
Measured: Target ulcer must achieve complete wound closure by 10 weeks post first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startApr 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
- 396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Alan Dunton, MD, Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849965
- Sponsor's protocol ID
- DSC127-2012-02
- Acronym
- STRIDE 2
- Status last verified
- Dec 2017
- First submitted
- 6 May 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 and Standard of Care-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
- NCT01849965
- Acronym / sponsor ID
- STRIDE 2 / DSC127-2012-02
- Conditions
- Diabetic Foot Ulcers
- Keywords
- diabetic foot ulcers, Wagner Grade 1 or 2 ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 May 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 determine if aclerastide (DSC127) is effective in increasing incidence of complete wound closure up to 10 weeks confirmed 2 weeks later, compared with vehicle (gel without active ingredient) and compared with a standard-of-care gel, in subjects with diabetes mellitus (DM) who have chronic Wagner Grade 1 or 2 diabetic foot ulcers, 0.75 - 6cm2 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 all other criteria are met. Four weeks of "blinded" randomized treatment follows the screening period, and an observation period of six weeks follows the treatment period. If the ulcer closes during the treatment or observation period, the closure will be confirmed at a visit two weeks later, and at this time the subjects 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
- 3
| 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 |
| Standard of Care gel | Placebo comparator | Drug: Standard of Care gel, AquasiteAquasite gel, as standard of care gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 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 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 or standard of care gel 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 occurs sooner. | Drug | DSC127 |
| placebo vehicle gel | Drug | Vehicle gel |
| Standard of Care gel, Aquasite | Drug | Standard of Care gel |
Primary outcome
The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed 2 weeks later) after initiation of treatment.
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 via tracings submitted to the Canfield system, and photographs are collected as confirmation of closure via the Canfield system. Assessment of aclerastide (DSC127) vs vehicle control.
1 secondary outcome
The proportion of subjects with a target ulcer which achieves complete wound closure by 10 weeks (confirmed two weeks later) after initiation of treatment.
Time frame: Target ulcer must achieve complete wound closure by 10 weeks post first treatment
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.
Alan Dunton, MD study director
Integra LifeSciences Corporation
56 sites in 4 countries: 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 56 sites in 4 countries.
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 18 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 56 sites in United States, South Africa, Canada, Puerto Rico. 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 by 10 weeks (confirmed 2 weeks later) after initiation of treatment. (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.