Diabetic Foot UlcersPhase 4NCT02111291
Santyl Applications to Diabetic Foot Ulcers
A Phase 4 study testing Collagenase SANTYL® Ointment and Hydrogel (if needed) and foam dressing in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint at 25 sites in 2 countries.
Trial summary
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- What is being tested?
- Collagenase SANTYL® Ointment and Hydrogel (if needed) and foam dressing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Apr 2014to Dec 2015
- Phase
- Phase 4
- 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
- Subjects will be considered qualified for enrollment if they meet the following criteria:
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
- Eighteen (18) years of age or older, of either sex, and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Willing and able to make all required study visits.
- Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
- Willing to use an appropriate off-loading device whenever necessary to keep weight off of any foot ulcers.
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- An ulcer present on any part of the plantar surface of the foot or plantar surface of the hallux which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 6 weeks but not more than 52 weeks (12 months) documented in the patient's history or by patient report of onset which requires debridement.
- Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.70 and ≤ 1.20. If ABI > 1.2, perfusion at or near the site of the ulcer should be confirmed; the foot is warm to the touch and has palpable pulses.
- Separation of at least 5 cm (closest ulcer edge to other closest ulcer edge) if ≥ 2 ulcers are present.
- Diabetes mellitus (Type 1 or 2) requiring insulin or oral/injectable medications to control blood glucose levels.
- Target ulcer is not infected based on clinical assessment.
Who cannot join
- Any one (1) of the following criteria will disqualify a potential Subject from participation in the study.
- Contraindications or hypersensitivity to the use of clostridial collagenase or hydrogel.
- Undergoing therapy with another investigational agent within thirty (30) days of Visit 1, or planned participation overlapping with this study.
- Bleeding disorder that would preclude sharp debridement during the study.
- Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
- Infection with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, azotemia).
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- A target ulcer which involves the underlying tissues of tendon, muscle, or bone.
- Diagnosis of chronic granulomatous disease, leukocyte adhesion defects, or severe neutropenia.
- Current treatment (at the time of the Screening Visit) with any of the following:
- Systemic corticosteroids. If corticosteroid treatment was for ≥ 10 days, there must be a 1 week interval between discontinuation and screening.
- Immunosuppressive agents
- Chemotherapeutic agents
- Antiviral agents
- Systemic antibiotic therapy or topical antibiotic treatment of the target ulcer
- Treatment of target ulcer with bioactive therapies within 1 month of screening:
- Platelet-derived growth factor (e.g., Regranex)
- Living skin equivalent (e.g., Apligraf)
- Dermal substitute (e.g., Dermagraft, Integra, Oasis, etc.)
- Treatment of target ulcer for any length of time with clostridial collagenase ointment (SANTYL®) if within 12 weeks prior to screening.
- Target ulcer that failed to develop well-established granulation tissue when treated with clostridial collagenase ointment (SANTYL®) for at least 4 weeks.
- Radiation therapy to the target lower extremity within 30 days prior to screening.
- Medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Blood counts and blood chemistry values as follows:
- Alanine aminotransferase (ALT) > 3x upper limit of normal
- Aspartate aminotransferase (AST) > 3x upper limit of normal
- Gamma Glutamyl Transferase (GGT) > 2.5x upper limit of normal
- Serum albumin < 2.0 g/dL • Pre-albumin levels of < 10 mg/dL
- Alkaline phosphatase > 500 U/L • Serum total bilirubin > 3.0 mg/dL
- Serum BUN > 75 mg/dL • Serum creatinine > 4.5 mg/dL
- HbA1c > 12% • Hemoglobin (Hgb) < 8.0 g/dL
- WBC < 2.0 x 109/L • Absolute neutrophil count < 1.0 x 109/L
- Platelet count < 50 x 109/L • INR > 1.5x upper limit of normal
- Furthermore, prior to randomization at Visit 1, the following exclusion criteria will apply:
- Use of excluded concomitant medications or therapies between Screening and Visit 1.
- A clinically diagnosed infection of the target ulcer requiring treatment.
- Muscle, tendon, or bone exposure in the target ulcer.
- After debridement at Visit 1, the ulcer area is >12 cm2.
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States22 sites
Study site
Baltimore, Maryland, 21215
Study site
Carlsbad, California, 92009
Study site
Castro Valley, California, 94546
Study site
Doral, Florida, 33178
Study site
Fair Oaks, California, 95628
Study site
Fort Worth, Texas, 76104
Study site
Fresno, California, 93720
Study site
Greenville, North Carolina, 27834
Study site
Kansas City, Missouri, 64114
Study site
Las Vegas, Nevada, 89119
Study site
McAllen, Texas, 78501
Study site
Mesa, Arizona, 85206
Study site
New York, New York, 10025
Study site
Reading, Pennsylvania, 19610
Study site
Roanoke, Virginia, 24013
Study site
Shreveport, Louisiana, 71101
Study site
St. George, Utah, 84770
Study site
Sylmar, California, 91342
Study site
Temple, Texas, 76504
Study site
Virginia Beach, Virginia, 23464
Study site
Warner Robins, Georgia, 31093
Study site
York, Pennsylvania, 17402
Canada3 sites
Study site
Calgary, Alberta, T2T 5C7
Study site
Hamilton, Ontario, L8R2R3
Study site
Montreal, Quebec, J4B 5E4
About this study
Official title: Clinical Outcomes Associated With Enzymatic Debridement of Diabetic Foot Ulcers for Up To 12 Weeks With Clostridial Collagenase (Santyl®) Ointment
The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Being tested
- Collagenase SANTYL® Ointment, Hydrogel (if needed) and foam dressing
- Keywords
- Diabetic 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.
Collagenase SANTYL® OintmentBiological
Daily application directly to the ulcer bed, approximately 2 mm thick.
Hydrogel (if needed) and foam dressingBiological
Daily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing
| Study group | Role | What they receive |
|---|---|---|
| SANTYL® | Experimental | Not described Receives: Biological: Collagenase SANTYL® Ointment |
| Supportive Care | Sham comparator | Not described Receives: Biological: Hydrogel (if needed) and foam dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Well-established Granulation Tissue
Measured: 12 Weeks
Secondary outcomes (1)
Adverse Event
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hebert B Slade, MD, Study chair, Smith and Nephew Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111291
- Sponsor's protocol ID
- 017-101-09-034
- Status last verified
- Feb 2016
- First submitted
- 9 Apr 2014
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Associated With Enzymatic Debridement of Diabetic Foot Ulcers for Up To 12 Weeks With Clostridial Collagenase (Santyl®) Ointment
- ClinicalTrials.gov ID
- NCT02111291
- Acronym / sponsor ID
- 017-101-09-034
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Keywords
- Diabetic Foot Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Apr 2014 (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 current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SANTYL® | Experimental | Biological: Collagenase SANTYL® Ointment |
| Supportive Care | Sham comparator | Biological: Hydrogel (if needed) and foam dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information.
- Eighteen (18) years of age or older, of either sex, and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- Willing and able to make all required study visits.
- Able to follow instructions and perform the dressing changes at home or have a caregiver who can perform the dressing changes according to the protocol.
- Willing to use an appropriate off-loading device whenever necessary to keep weight off of any foot ulcers.
Key exclusion criteria (37 listed)
- Any one (1) of the following criteria will disqualify a potential Subject from participation in the study.
- Contraindications or hypersensitivity to the use of clostridial collagenase or hydrogel.
- Undergoing therapy with another investigational agent within thirty (30) days of Visit 1, or planned participation overlapping with this study.
- Bleeding disorder that would preclude sharp debridement during the study.
- Active cellulitis of the target ulcer, lymphangitic streaking, deep tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
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 |
|---|---|---|
| Collagenase SANTYL® OintmentDaily application directly to the ulcer bed, approximately 2 mm thick. | Biological | SANTYL® |
| Hydrogel (if needed) and foam dressingDaily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing | Biological | Supportive Care |
Primary outcome
Time to Well-established Granulation Tissue
Time frame: 12 Weeks
1 secondary outcome
Adverse Event
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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EDX110 Randomized Control Trial for Treatment of DFUs
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
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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.
Hebert B Slade, MD study chair
Smith and Nephew Biotherapeutics
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase SANTYL® Ointment and Hydrogel (if needed) and foam dressing in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint at 25 sites in 2 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 11 inclusion and 37 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 17 Feb 2016. 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, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Well-established Granulation Tissue (time frame: 12 Weeks). 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 17 Feb 2016.