Clinical trial NCT01056198: Santyl vs. Sharp Debridement of Diabetic Foot Wounds
Official title: Comparison of Sharp Surgical Debridement Versus Collagenase Santyl Ointment in the Care of Diabetic Foot Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Foot Ulcers
Foot Wounds
Keywords: Diabetic Foot Ulcers
Diabetic Foot Wounds
Lead sponsor: Healthpoint
Sponsor class: INDUSTRY
First posted: 2010-01-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tests two different approaches to the removal of dead tissue from the surface of a wound.


Eligibility criteria: Inclusion Criteria:

* The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
* 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.
* Willing 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 the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase.
* A history of Type I or Type II Diabetes Mellitus requiring insulin or oral hypoglycemic medications to normalize blood glucose levels.

A foot wound which is:

* Superficial, involving the full skin thickness but not underlying tissues and is 0.5 cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided)
* Chronic, defined as open for 30 days
* On a neuropathic foot, defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area
* Adequately perfused, defined as TcPO2 \> 40 mmHg; or toe pressure \> 40 mmHg, or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening.

  * Acceptable state of health and nutrition with:
* Serum albumin ≥ 2.0 g/dL (20g/L)
* Pre-albumin levels of ≥ 15 mg/dL (0.15g/L).

  * Per Screening lab chemistry† report:
* 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 blood urea nitrogen (BUN) \< 75 mg/dL
* Serum creatinine 4.5 mg/dL
* HbA1c 12%

  * Per Screening lab hematology† report:
* Hemoglobin (Hgb) \> 8.0 g/dL
* White blood cells (WBC) \> 2.0 109/L
* Absolute neutrophil count \> 1.0 109/L
* Platelet count \> 50 109/L.

  * Local laboratories will be used, but the ranges for inclusion are set based on Healthpoint Data Management ranges. Refer to Appendix 18.1.2.

Exclusion Criteria:

* Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels).
* Target wound does not require debridement, or is covered with dry eschar.
* Uncontrolled bleeding disorder.
* Untreated cellulitis extending \>2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
* Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia).
* Any of the following:

  * Target wound tunneling per probing and visual assessment
  * Osteomyelitis of the target foot or wound probes to bone
  * Target wound is on the heel
  * Target wound is over a Charcot deformity which cannot be offloaded.
* Diagnosis of chronic granulomatous disease, leukocyte adhesion defects or severe neutropenia
* Treatment with any of the following:

  * Systemic corticosteroids
  * Immunosuppressive agent(s)
  * Chemotherapeutic agent(s)
  * Antiviral agent(s)
  * Platelet-derived growth factor
  * Living skin equivalent
  * Dermal substitute
  * Radiation therapy to the target lower extremity within 30 days prior to signing the informed consent document.
  * Currently on systemic antibiotic therapy
* Any medical condition judged by the Medical Monitor and/or Investigator to cause the study to be detrimental to the subject (specify on the reason for screen failure if this applies).

Primary outcomes:
measure: Bates-Jensen Wound Assessment Score - Modified (BWAT-m)
timeFrame: baseline and 28 days
Secondary outcomes:
measure: Percent of Wound Area Change From Baseline at End of Treatment
timeFrame: baseline and 28 days
measure: Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up
timeFrame: baseline and 84 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Foot Research
state: Arizona
city: Lincoln
country: United States
facility: St. Elizabeth Regional Medical Center
state: Nebraska
city: Altoona
country: United States
facility: Advanced Regional Center for Ankle and Foot Care
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company, Inc.
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center
state: Texas
city: Fort Worth
country: United States
facility: UNTHSC Fort Worth
state: Texas
city: San Antonio
country: United States
facility: Robert Wunderlich
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
Study officials:
affiliation: Healthpoint, Ltd.
name: Herbert B Slade, MD
role: STUDY_CHAIR
affiliation: Healthpoint, Ltd
name: Herbert B Slade, MD
role: STUDY_DIRECTOR
References:
citation: Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB; Collagenase Diabetic Foot Ulcer Study Group. Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study. Clin Ther. 2013 Nov;35(11):1805-20. doi: 10.1016/j.clinthera.2013.09.013. Epub 2013 Oct 18.