Santyl vs. Sharp Debridement of Diabetic Foot Wounds

NCT ID: NCT01056198

Last Updated: 2012-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-11-30

Brief Summary

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

Conditions

Diabetic Foot Ulcers; Foot Wounds

Keywords

Diabetic Foot Ulcers; Diabetic Foot Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Santyl

2 mm Santyl applied once daily

Group Type: ACTIVE_COMPARATOR

Santyl

Intervention Type: DRUG

2 mm Santyl applied once daily.

Control

Daily gauze and optional sharp debridement

Group Type: SHAM_COMPARATOR

Control

Intervention Type: PROCEDURE

Daily gauze and optional sharp debridement

Interventions

Santyl

2 mm Santyl applied once daily.

Intervention Type: DRUG

Control

Daily gauze and optional sharp debridement

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healthpoint

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Herbert B Slade, MD

Role: STUDY_CHAIR

Healthpoint, Ltd.

Herbert B Slade, MD

Role: STUDY_DIRECTOR

Healthpoint, Ltd

Locations

Foot Research

Phoenix, Arizona, United States

St. Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Advanced Regional Center for Ankle and Foot Care

Altoona, Pennsylvania, United States

St. Mary Medical Center

Langhorne, Pennsylvania, United States

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, United States

Arlington Research Center

Arlington, Texas, United States

UNTHSC Fort Worth

Fort Worth, Texas, United States

Robert Wunderlich

San Antonio, Texas, United States

Providence Health Center

Waco, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24145042 (View on PubMed)

Other Identifiers

017-101-09-028

Identifier Type: -

Identifier Source: org_study_id