Effectiveness Study of Santyl Ointment to Treat Pressure Ulcers

NCT01208220 | Terminated Results DMC

• 1 other identifier: Healthpoint-123-Collagenase
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers at LSUHSC-S hope to learn the effects of the combination of a medication and a device which by themselves are effective for the treatment of wounds. You are being asked to take part in this study because you have a wound on your body which has not responded to standard treatments. The researchers will be studying whether the combination of two treatments will make wounds heal faster. For those in study, the investigators will treat them with a vacuum device on their wound. Also, some of the people in the study will receive a special ointment and researchers will use special tests to determine if the two treatments together are working better than just one treatment alone.

Conditions

Pressure Ulcer; Soft Tissue Necrosis Lower Limb

Keywords

Collagenase Santyl; Enzymatic debridement; maintenance debridement; VAC; NPWT

Outcome Measures

Primary Outcomes (1)

• Quicker Filling of the Wound With Good Tissue (vs. Treatment With NPWT Alone)

  2 weeks into study

Secondary Outcomes (1)

• Removal of Harmful Fluids in the Wound Tissue

  2 weeks into study

Study Arms (2)

Negative pressure wound therapy

ACTIVE COMPARATOR

NPWT changed TIW

Device: Negative Pressure Wound Therapy

NPWT plus Collagenase Ointment

EXPERIMENTAL

Collagenase applied TIW with NPWT

Biological: Collagenase Ointment

Interventions

Negative Pressure Wound Therapy DEVICE

NPWT changed 3 times weekly

Also known as: NPWT

Negative pressure wound therapy

Collagenase Ointment BIOLOGICAL

Apply TIW

NPWT plus Collagenase Ointment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 year-old competent adults in inpatient setting (no prisoners, mentally ill, or children)
• Pressure ulcers to pelvis/abdomen/trunk and or upper extremities which have been refractory to prior treatment interventions and contain less than or equal to 25% necrotic tissue in wound bed (as percentage of total surface area)

You may not qualify if:

• Lower extremity/foot wounds related to arterial insufficiency, incarcerated individuals, patients with untreated osteomyelitis, uncorrected coagulopathy, malignancy, sensitivity to collagenase, wounds with evidence of clinical infection (via swab culture or punch biopsy)

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• Healthpoint: collaborator

Study Sites (1)

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Negative-Pressure Wound Therapy; Collagenases

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Limitations and Caveats

No adverse events noted or reported

Results Point of Contact

• Title: Dr. Stanley McCallon
• Organization: LSUShreveport

smccal@lsushc.edu

318-813-2996

Study Officials

• Stanley K McCallon, DPT

  LSUHSC professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - School of Physical Therapy

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: September 23, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-07

Locations

US (1)