Foot Ulcer, DiabeticPhase 2NCT00796744
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
A Phase 2 study testing NorLeu3-A(1-7) in a gel formulation in people with Foot Ulcer, Diabetic and Diabetic Foot, run by US Biotest, Inc. at 12 sites in United States.
Trial summary
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic, Diabetic Foot
- What is being tested?
- NorLeu3-A(1-7) in a gel formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2008to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.
- ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU
- TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg
- Type I or Type II diabetes under metabolic control
- Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study
Who cannot join
- Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
- Chronic renal insufficiency and/or chronic liver dysfunction
- Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
- Malignancy of any kind
- Receiving hemodialysis or CAPD
- Current history of drug abuse, and/or known to be HIV positive
Show all 12Show fewer
- Prior radiation therapy of the foot under study
- Current use of corticosteroids (within past 8 weeks), immunosuppressants (within past 8 weeks), or use of a biologic agent to include growth factors and skin equivalents (Regranex, Apligraft, or Dermagraft) in the past 90 days
- Ulcer is deemed clinically infected and requires topical antimicrobials or agents known to affect wound healing, or the subject has been taking systemic antibiotics for more than 7 days for any reason
- Sickle-cell anemia, Raynaud's or other peripheral vascular disease
- Wagner Grade 3 or higher DU, deep abscess or infection of the joint or tendon, or gangrene or osteomyelitis
- An EKG with a marked baseline prolongation of QT/QTc interval
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Boston University School of Medicine
Boston, Massachusetts, 02118
Bay Area Footcare
Castro Valley, California, 94546
Renaissance Hospital Dallas
Dallas, Texas, 75224
Georgetown University Medical Center
Georgetown, Maryland, 20007
Eastern Carolina Foot & Ankle Specialists
Greenville, North Carolina, 27834
Passavant Area Hospital
Jacksonville, Illinois, 62650
Professional Education and Research Institute
Roanoke, Virginia, 24016
University of California, San Diego
San Diego, California, 92103-8896
Olive View - UCLA Medical Center
Sylmar, California, 91342-1438
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Southern Arizona Limb Salvage Alliance (SALSA)
Tucson, Arizona, 85724
Warren General Hospital Wound Clinic
Warren, Pennsylvania, 16365
About this study
Official title: Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers
The purpose of this study is to assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
Read the detailed description
This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC127 and placebo (n = 25 evaluable subjects per group; n=75 total evaluable subjects) to identify the optimal dose of DSC127. Sustained tissue integrity will be evaluated for all subjects during a follow-up period at study weeks 16 and 24.
Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups.
Group 1: Placebo Vehicle Control Group 2: 0.03% DSC127 in Vehicle Group 3: 0.01% DSC127 in Vehicle
The four week treatment period requires daily application of the treatment to the wound site. First application each week will be at the clinic and for the remainder of the week the patient self-administers the treatment.
If wound healing occurs during the treatment or assessment periods a final assessment visit is conducted and the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).
- Conditions
- Foot Ulcer, Diabetic, Diabetic Foot
- Being tested
- NorLeu3-A(1-7) in a gel formulation
- Keywords
- Diabetes mellitus, Diabetic neuropathy, Peripheral vascular disease, Infection, Topical application, plantar foot ulcers
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Diabetic Neuropathies, Peripheral Vascular Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorLeu3-A(1-7) in a gel formulationDrug
Also called NorLeu3-Angiotensin(1-7), DSC127
Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Vehicle Control | Placebo comparator | control placebo vehicle gel Receives: Drug: NorLeu3-A(1-7) in a gel formulation |
| 0.03% DSC127 | Active comparator | 0.03 % DSC127 in Vehicle Control Receives: Drug: NorLeu3-A(1-7) in a gel formulation |
| 0.01% DSC127 | Active comparator | 0.01% DSC127 in Vehicle Control Receives: Drug: NorLeu3-A(1-7) in a gel formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.
Measured: Healing to occur within 12 weeks of first treatment
Secondary outcomes (3)
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Measured: Duration of subject's participation (24 weeks)
The Rate of Re-epithelialization of the Ulcer Site.
The overall healing rate of the ulcers, based on the percent of unhealed ulcer area re-epithelialized per week.
Measured: 12 weeks
The Time to Re-epithelialization of the Ulcer Site.
Average time to complete re-epithelialization of baseline ulcer area.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionMay 2011
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 (5)Papers the sponsor has linked to this study.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Biotest, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Integra LifeSciences Corporation
- Responsible party
- Sponsor
- Investigators
- Gere diZerega, MD, Study director, US Biotest, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796744
- Sponsor's protocol ID
- DSC127-2008-01
- Status last verified
- Aug 2012
- First submitted
- 20 Nov 2008
- Last updated
- 27 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rodgers KE, Ellefson DD, Espinoza T, Roda N, Maldonado S, Dizerega GS. Effect of NorLeu3-A(1-7) on scar formation over time after full-thickness incision injury in the rat. Wound Repair Regen. 2005 May-Jun;13(3):309-17. doi: 10.1111/j.1067-1927.2005.130314.x.
PubMed 15953051Rodgers KE, Espinoza T, Felix J, Roda N, Maldonado S, diZerega G. Acceleration of healing, reduction of fibrotic scar, and normalization of tissue architecture by an angiotensin analogue, NorLeu3-A(1-7). Plast Reconstr Surg. 2003 Mar;111(3):1195-206. doi: 10.1097/01.PRS.0000047403.23105.66.
PubMed 12621191Rodgers K, Xiong S, Felix J, Roda N, Espinoza T, Maldonado S, Dizerega G. Development of angiotensin (1-7) as an agent to accelerate dermal repair. Wound Repair Regen. 2001 May-Jun;9(3):238-47. doi: 10.1046/j.1524-475x.2001.00238.x.
PubMed 11472620Rodgers KE, Roda N, Felix JE, Espinoza T, Maldonado S, diZerega G. Histological evaluation of the effects of angiotensin peptides on wound repair in diabetic mice. Exp Dermatol. 2003 Dec;12(6):784-90. doi: 10.1111/j.0906-6705.2003.00087.x.
PubMed 14714558Balingit PP, Armstrong DG, Reyzelman AM, Bolton L, Verco SJ, Rodgers KE, Nigh KA, diZerega GS. NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Wound Repair Regen. 2012 Jul-Aug;20(4):482-90. doi: 10.1111/j.1524-475X.2012.00804.x. Epub 2012 Jun 7.
PubMed 22672145
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial to Evaluate the Safety and Effectiveness of DSC127 in Treating Subjects With Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00796744
- Acronym / sponsor ID
- DSC127-2008-01
- Conditions
- Foot Ulcer, Diabetic, Diabetic Foot
- Keywords
- Diabetes mellitus, Diabetic neuropathy, Peripheral vascular disease, Infection, Topical application, plantar foot ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- US Biotest, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), Integra LifeSciences Corporation
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 27 Sep 2012
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 assess if the experimental drug, DSC127, is safe, how well it can be tolerated, and how different doses effect the healing of the chronic foot ulcers in diabetic subjects.
Detailed description
This study is designed as a randomized, parallel-group, double-blind, placebo-controlled trial. After a 14-day baseline to evaluate ulcer healing to ensure DU are chronic, a 4-week active treatment followed by 8 weeks of observation and assessment of the treatment will compare the effects of two concentrations of DSC127 and placebo (n = 25 evaluable subjects per group; n=75 total evaluable subjects) to identify the optimal dose of DSC127. Sustained tissue integrity will be evaluated for all subjects during a follow-up period at study weeks 16 and 24.
Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups.
Group 1: Placebo Vehicle Control Group 2: 0.03% DSC127 in Vehicle Group 3: 0.01% DSC127 in Vehicle
The four week treatment period requires daily application of the treatment to the wound site. First application each week will be at the clinic and for the remainder of the week the patient self-administers the treatment.
If wound healing occurs during the treatment or assessment periods a final assessment visit is conducted and the integrity is assessed four and twelve weeks later (usually weeks 16 and 24 of the study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Vehicle Control | Placebo comparator | Drug: NorLeu3-A(1-7) in a gel formulationcontrol placebo vehicle gel |
| 0.03% DSC127 | Active comparator | Drug: NorLeu3-A(1-7) in a gel formulation0.03 % DSC127 in Vehicle Control |
| 0.01% DSC127 | Active comparator | Drug: NorLeu3-A(1-7) in a gel formulation0.01% DSC127 in Vehicle Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have at least one chronic non-healing Wagner Grade 1 or Grade 2 plantar neuropathic diabetic ulcer between 1.0-6.0 cm2 on the midfoot or forefoot, including the toes but excluding the heel.
- ABI greater than 0.7 for neuroischemic or greater than 0.8 for neuropathic DU
- TcPO2 greater than 40 mm Hg or great toe systolic pressure greater than 50 mmHg
- Type I or Type II diabetes under metabolic control
- Female subjects must have a negative pregnancy test and be willing to use acceptable method of birth control for the duration of the study
Key exclusion criteria (12 listed)
- Exposure to any investigational product within the last 30 days, or have known hypersensitivity to any of the study medication components
- Chronic renal insufficiency and/or chronic liver dysfunction
- Resting blood pressure (at the time of the initial visit of the Screening Period) which exceeds 160 systolic and/or 90 diastolic mmHg on 3 consecutive readings at least 15 minutes apart
- Malignancy of any kind
- Receiving hemodialysis or CAPD
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 |
|---|---|---|
| NorLeu3-A(1-7) in a gel formulationAlso: NorLeu3-Angiotensin(1-7), DSC127Gel will be applied to the wound once daily for four weeks (treatment period). Gel will have either no active ingredient (placebo), 0.03% or 0.01% active ingredient. | Drug | 0.01% DSC127, 0.03% DSC127, Placebo Vehicle Control |
Primary outcome
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage.
Time frame: Healing to occur within 12 weeks of first treatment
3 secondary outcomes
The Proportion of Subjects in Each Treatment Group Reporting Adverse Events.
Time frame: Duration of subject's participation (24 weeks)
The Rate of Re-epithelialization of the Ulcer Site.
Time frame: 12 weeks
The Time to Re-epithelialization of the Ulcer Site.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15953051Rodgers KE, Ellefson DD, Espinoza T, Roda N, Maldonado S, Dizerega GS. Effect of NorLeu3-A(1-7) on scar formation over time after full-thickness incision injury in the rat. Wound Repair Regen. 2005 May-Jun;13(3):309-17. doi: 10.1111/j.1067-1927.2005.130314.x.
- Background: PubMed 12621191Rodgers KE, Espinoza T, Felix J, Roda N, Maldonado S, diZerega G. Acceleration of healing, reduction of fibrotic scar, and normalization of tissue architecture by an angiotensin analogue, NorLeu3-A(1-7). Plast Reconstr Surg. 2003 Mar;111(3):1195-206. doi: 10.1097/01.PRS.0000047403.23105.66.
- Background: PubMed 11472620Rodgers K, Xiong S, Felix J, Roda N, Espinoza T, Maldonado S, Dizerega G. Development of angiotensin (1-7) as an agent to accelerate dermal repair. Wound Repair Regen. 2001 May-Jun;9(3):238-47. doi: 10.1046/j.1524-475x.2001.00238.x.
- Background: PubMed 14714558Rodgers KE, Roda N, Felix JE, Espinoza T, Maldonado S, diZerega G. Histological evaluation of the effects of angiotensin peptides on wound repair in diabetic mice. Exp Dermatol. 2003 Dec;12(6):784-90. doi: 10.1111/j.0906-6705.2003.00087.x.
- Results publication: PubMed 22672145Balingit PP, Armstrong DG, Reyzelman AM, Bolton L, Verco SJ, Rodgers KE, Nigh KA, diZerega GS. NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Wound Repair Regen. 2012 Jul-Aug;20(4):482-90. doi: 10.1111/j.1524-475X.2012.00804.x. Epub 2012 Jun 7.
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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 diZerega, MD study director
US Biotest, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NorLeu3-A(1-7) in a gel formulation in people with Foot Ulcer, Diabetic and Diabetic Foot, run by US Biotest, Inc. at 12 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 5 inclusion and 12 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 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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 27 Sep 2012). 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?
The Primary Efficacy Parameter Will be the Proportion of Ulcers Healed by 12 Weeks as Defined as 100 % Epithelialized With no Drainage. (time frame: Healing to occur within 12 weeks of first 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 NCT00796744, which also lists 5 linked publications.
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 Sep 2012.