Diabetic Foot UlcersPhase 4NCT01408277
Using Santyl on Diabetic Foot Ulcers
A Phase 4 study testing Santyl in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint at 7 sites in United States.
Trial summary
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. 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?
- Santyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2011to Mar 2013
- 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.
- Subjects 18 years of age or older. Subjects may be 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.
- A target ulcer which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 30 days (documented in the patient's history or by patient report of onset) which requires sharp surgical debridement.
- Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of > 40 mmHg OR a TcPO2 ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable as a stand-alone measurement, but if both are obtained, each must meet its respective cutoff.
- Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable.
- A target ulcer that is not infected based on clinical assessment.
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- 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.
- History of diabetes mellitus (Type 1 or 2) requiring insulin or oral hypoglycemic medications to control blood glucose levels.
- CBC and blood chemistry values as follows:
- Serum albumin ≥ 2.0 g/dL
- Pre-albumin levels of ≥ 15 mg/dL
- Alkaline phosphatase ≤ 500 U/L
- Alanine aminotransferase (ALT) ≤ 200 U/L
- Aspartate aminotransferase (AST) ≤ 175 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
Who cannot join
- Contraindications or hypersensitivity to the use of the study medications or their components.
- Target ulcer does not require debridement.
- Uncontrolled bleeding disorder.
- Cellulitis of the target wound, 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).
- Any of the following:
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- Target ulcer tunneling
- Target ulcer requires hyperbaric or negative pressure therapy per the investigator's medical judgment
- Target ulcer is on the heel and cannot be offloaded
- Target ulcer is over a Charcot deformity which cannot be offloaded
- NOTE: A heel ulcer or an ulcer over a Charcot is not excluded unless effective offloading is not possible.
- Current, ongoing osteomyelitis of the target foot as determined by medical history.
- Participation in another investigational clinical study within thirty (30) days of the Screening Visit.
- A target ulcer which involves underlying tissues (i.e., fat, fascia, tendon, muscle, bone).
- A target ulcer on a non-neuropathic foot (neuropathic defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area).
- NOTE: Monofilament test result must be documented.
- 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
- Immunosuppressive agents
- Chemotherapeutic agents
- Antiviral agents
- Platelet-derived growth factor (e.g., Regranex)
- Living skin equivalent (e.g., Apligraf)
- Dermal substitute (e.g., Dermagraft, Integra, etc.)
- Systemic antibiotic therapy or topical antibiotic treatment of the target ulcer
- Radiation therapy to the target lower extremity within 30 days prior to screening The Medical Monitor and/or Investigator may declare any subject ineligible for a valid medical reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
UNTHSC Fort Worth
Fort Worth, Texas, 76107
Associated Foot and Ankle Specialists
Phoenix, Arizona, 85015
Robert Wunderlich
San Antonio, Texas, 78212
Endeavor Clinical Trials
San Antonio, Texas, 78229
Foot Healthcare Associates, PC
Southfield, Michigan, 48076
Overlook Hospital Wound Care Center
Summit, New Jersey, 07901
Aung Foothealth Clinics
Tucson, Arizona, 85710
About this study
Official title: A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound.
This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Being tested
- Santyl, Control
- Keywords
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SantylBiological
2 mm Santyl applied once daily
ControlProcedure or surgery
Also called Standard Care
Standard Care
| Study group | Role | What they receive |
|---|---|---|
| Santyl | Active comparator | 2mm Santyl applied once daily. Receives: Biological: Santyl |
| Control | Active comparator | Standard Care Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Wound Area
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionMar 2013
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 (1)Papers the sponsor has linked to this study.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Healthpoint
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408277
- Sponsor's protocol ID
- 017-101-09-030
- Status last verified
- Jun 2014
- First submitted
- 2 Aug 2011
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Motley TA, Gilligan AM, Lange DL, Waycaster CR, Dickerson JE Jr. Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial. J Foot Ankle Res. 2015 Feb 28;8:7. doi: 10.1186/s13047-015-0065-x. eCollection 2015.
PubMed 25767565
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Collagenase Santyl® Ointment Used Adjunctively to Sharp Surgical Debridement and Sharp Surgical Debridement in the Care of Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT01408277
- Acronym / sponsor ID
- 017-101-09-030
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Keywords
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects enrolled in this study will either use Santyl daily or follow standard care procedures for up to 6 weeks for their diabetic foot wound. After 6 weeks of treatment, the subjects will continue into the follow-up phase for an additional 6 weeks. Study doctors will look at the wound in the office each week (up to 12 weeks) to see if the wound is healing. Depending on a number of factors at each office visit, the study doctors may also use a procedure called sharp debridement to remove dead skin from the wound.
This study will test the hypothesis that daily treatment of diabetic foot wounds with Santyl will result in more rapid healing, healthier wounds, and fewer required sharp debridements over the study period than for diabetic foot wounds treated in other ways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Santyl | Active comparator | Biological: Santyl2mm Santyl applied once daily. |
| Control | Active comparator | Procedure: ControlStandard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 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.
- Subjects 18 years of age or older. Subjects may be 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.
- A target ulcer which is 0.5 cm2 - 10 cm2 inclusive (as measured at the Screening Visit) with a duration ≥ 30 days (documented in the patient's history or by patient report of onset) which requires sharp surgical debridement.
- Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.7 and ≤ 1.1. If the ABI is greater than 1.1, then a toe pressure of > 40 mmHg OR a TcPO2 ≥ 40 mmHg must be present. Either toe pressure or TcPO2 is also acceptable as a stand-alone measurement, but if both are obtained, each must meet its respective cutoff.
- Alternatively, a Doppler waveform consistent with adequate flow to the region of the foot with the target ulcer (biphasic or triphasic waveforms) is acceptable.
Key exclusion criteria (27 listed)
- Contraindications or hypersensitivity to the use of the study medications or their components.
- Target ulcer does not require debridement.
- Uncontrolled bleeding disorder.
- Cellulitis of the target wound, 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 |
|---|---|---|
| Santyl2 mm Santyl applied once daily | Biological | Santyl |
| ControlAlso: Standard CareStandard Care | Procedure or surgery | Control |
Primary outcome
Mean Percent Change in Wound Area
Time frame: 6 and 12 weeks
Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25767565Motley TA, Gilligan AM, Lange DL, Waycaster CR, Dickerson JE Jr. Cost-effectiveness of clostridial collagenase ointment on wound closure in patients with diabetic foot ulcers: economic analysis of results from a multicenter, randomized, open-label trial. J Foot Ankle Res. 2015 Feb 28;8:7. doi: 10.1186/s13047-015-0065-x. eCollection 2015.
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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.
Herbert B Slade, MD study chair
Healthpoint
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Santyl in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint at 7 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 24 inclusion and 27 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 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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 5 May 2014). 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 Wound Area (time frame: 6 and 12 weeks). 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 NCT01408277, which also lists 1 linked publication.
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 24 Jul 2014.