Diabetic FootPhase 4NCT02581488
Use of Santyl in Diabetic Foot Ulcers
A Phase 4 study testing Santyl and Product containing silver in people with Diabetic Foot and Foot Ulcer, Diabetic, run by Smith & Nephew, Inc. at 13 sites in 2 countries.
Trial summary
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Foot Ulcer, Diabetic
- What is being tested?
- Santyl and Product containing silver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Oct 2015to 12 Jan 2017
- Phase
- Phase 4
- 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
- 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.
- 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 to keep weight off of foot ulcers.
- An ulcer present on any part of the plantar surface of the neuropathic foot or hallux which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit using the ARANZ Silhouette imaging device). The target ulcer duration must be ≥ 6 weeks but not more than 52 weeks (12 months) as documented in the subject's history or by subject report of onset, and which requires debridement.
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- 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 as measured using the ARANZ Silhouette imaging device.
- 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
- Contraindications or hypersensitivity to the use of clostridial collagenase or products containing silver.
- Participation in another clinical trial 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).
- A target ulcer which involves the underlying tissues of tendon, muscle, or bone.
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- 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 (for any reason) 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.)
- Amniotic membrane products (e.g., EpiFix®, Grafix®, etc.)
- Prior treatment of target ulcer for any length of time with clostridial collagenase ointment (SANTYL®).
- 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Study site
Baltimore, Maryland, 21215
Study site
Fort Worth, Texas, 76107
Study site
Harrisonburg, Virginia, 22801
Study site
Las Vegas, Nevada, 89119
Study site
McAllen, Texas, 78501
Study site
Melbourne, Florida, 32935
Study site
Roanoke, Virginia, 24013
Study site
St. George, Utah, 84770
Study site
Sylmar, California, 91342
Study site
Virginia Beach, Virginia, 23464
Study site
York, Pennsylvania, 17402
Canada2 sites
Study site
Boucherville, Quebec, J4B 5E4
Study site
Hamilton, Ontario, L8R 2R3
About this study
Official title: Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.
Read the detailed description
The objectives of this study were to compare outcomes of diabetic foot ulcers (DFUs) treated with SANTYL or silver-containing products, both in combination with sharp debridement as needed. One hundred two subjects with qualifying DFUs were randomized to daily treatment with either SANTYL or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.
- Conditions
- Diabetic Foot, Foot Ulcer, Diabetic
- Being tested
- Santyl, Product containing silver
- Keywords
- Diabetes, diabetic foot ulcer, foot sore, type 2 diabetes, type 1 diabetes, neuropathy, DFU
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SantylBiological
Product containing silverOther
Silver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer
| Study group | Role | What they receive |
|---|---|---|
| Santyl | Experimental | Collagenase ointment applied topically once per day for up to six weeks. Receives: Biological: Santyl |
| Product containing silver | Active comparator | Products containing silver will be applied per Investigator instructions and instructions for use/package insert for up to six weeks. Receives: Other: Product containing silver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.
Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.
Measured: 6 weeks
Secondary outcomes (1)
Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion12 Jan 2017
- Study completion12 Jan 2017
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.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Eichelkraut, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581488
- Sponsor's protocol ID
- 017-101-09-035
- Status last verified
- May 2018
- First submitted
- 19 Oct 2015
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes for Diabetic Foot Ulcers Treated With Clostridial Collagenase (SANTYL®) Ointment or With a Comparator Product Containing Silver
- ClinicalTrials.gov ID
- NCT02581488
- Acronym / sponsor ID
- 017-101-09-035
- Conditions
- Diabetic Foot, Foot Ulcer, Diabetic
- Keywords
- Diabetes, diabetic foot ulcer, foot sore, type 2 diabetes, type 1 diabetes, neuropathy, DFU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- 12 Jan 2017 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 1 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that daily treatment of diabetic foot ulcers with an enzymatic debriding agent, SANTYL, for up to 6 weeks will result in more rapid decrease in ulcer area than diabetic foot ulcers treated with a topical treatment containing silver. After meeting study criteria, participants will be randomly assigned to apply SANTYL or a topical treatment containing silver to their to foot ulcer for up to 6 weeks. At the end of 6 weeks, participants will be followed for an additional 4 weeks to examine the outcome of the study treatment.
Detailed description
The objectives of this study were to compare outcomes of diabetic foot ulcers (DFUs) treated with SANTYL or silver-containing products, both in combination with sharp debridement as needed. One hundred two subjects with qualifying DFUs were randomized to daily treatment with either SANTYL or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.
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: SantylCollagenase ointment applied topically once per day for up to six weeks. |
| Product containing silver | Active comparator | Other: Product containing silverProducts containing silver will be applied per Investigator instructions and instructions for use/package insert for up to six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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.
- 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 to keep weight off of foot ulcers.
Key exclusion criteria (31 listed)
- Contraindications or hypersensitivity to the use of clostridial collagenase or products containing silver.
- Participation in another clinical trial 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).
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 |
|---|---|---|
| Santyl | Biological | Santyl |
| Product containing silverSilver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer | Other | Product containing silver |
Primary outcome
Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.
Time frame: 6 weeks
Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.
1 secondary outcome
Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Eichelkraut study chair
Smith & Nephew, Inc.
13 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 Santyl and Product containing silver in people with Diabetic Foot and Foot Ulcer, Diabetic, run by Smith & Nephew, Inc. at 13 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 10 inclusion and 31 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 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2018). 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?
Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment. (time frame: 6 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 1 Aug 2018.