Santyl vs. Sharp Debridement of Diabetic Foot Wounds

Phase 4

Completed

Conditions: Diabetic Foot Ulcers
Foot Wounds

Interventions: Drug: Santyl
Procedure: Control

Registration Number: NCT01056198

Lead Sponsor: Healthpoint

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Santyl	Santyl	2 mm Santyl applied once daily
Control	Control	Daily gauze and optional sharp debridement

Primary Outcome Measures

Name	Time	Method
Bates-Jensen Wound Assessment Score - Modified (BWAT-m)	baseline and 28 days	The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).

Secondary Outcome Measures

Name	Time	Method
Percent of Wound Area Change From Baseline at End of Treatment	baseline and 28 days
Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up	baseline and 84 days

Trial Locations

Locations (9): St. Elizabeth Regional Medical Center
🇺🇸
Lincoln, Nebraska, United States
UNTHSC Fort Worth
🇺🇸
Fort Worth, Texas, United States
Advanced Regional Center for Ankle and Foot Care
🇺🇸
Altoona, Pennsylvania, United States
Arlington Research Center
🇺🇸
Arlington, Texas, United States
Foot Research
🇺🇸
Phoenix, Arizona, United States
Robert Wunderlich
🇺🇸
San Antonio, Texas, United States
St. Mary Medical Center
🇺🇸
Langhorne, Pennsylvania, United States
Paddington Testing Company, Inc.
🇺🇸
Philadelphia, Pennsylvania, United States
Providence Health Center
🇺🇸
Waco, Texas, United States