Negative Pressure Wound Therapy as a Drug Delivery System (ADANPWT)

NCT02308800 | Withdrawn

• 1 other identifier: 092014-016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan a randomized clinical trial of 150 patients with infected diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of negative pressure wound therapy with continuous irrigation and negative pressure wound therapy without irrigation. The investigators will enroll 150 patients from two centers: The University of Texas Southwestern University Hospital and Parkland Hospital. The investigators will screen and enroll patients with wounds in the inpatient setting. Patients will randomized to receive traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average hospitalization for patents that receive NPWT is 13.3 days. Patients that do not have their wound surgically closed during hospitalization will be discharged with negative pressure wound therapy without irrigation for up to a total of four weeks of therapy. After discharge from the hospital, subjects will be seen twice weekly by home health, and the investigators will evaluate subjects in clinic every 7 days (±7 days) for a total of 16-week period or until the wound heals.

Conditions

Foot Ulcer, Diabetic

Keywords

diabetic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Compare clinical outcomes (time to wound healing, number of surgeries) with Negative Pressure Wound Therapy with irrigation and Negative Pressure Wound Therapy without irrigation.

  The investigators expect that patients treated with NPWT with irrigation will a have higher proportions of wounds that heal, fewer surgeries, and faster wound healing trajectories when compared to patients treated with traditional NPWT without irrigation.

  Up to 12 weeks

Secondary Outcomes (1)

• Compare quantitative cultures (bacterial load as measured by qPCR) and number of clinical infections in patients treated with NPWT with irrigation compared to conventional NPWT.

  Up to 12 weeks

Other Outcomes (1)

• Compare responses to the HR-QOL questionnaires of patients treated with NPWT with irrigation compared to conventional NPWT.

  Up to 12 weeks

Study Arms (2)

Quantum™ Therapy/NPWT with Prontosan

ACTIVE COMPARATOR

Quantum™ Negative Pressure Wound Therapy with Prontosan irrigant.

Device: Quantum™ Therapy - NPWT with Prontosan

Quantum™ Therapy

ACTIVE COMPARATOR

Quantum™ Negative Pressure Wound Therapy without irrigant.

Device: Quantum™ Therapy

Interventions

Quantum™ Therapy - NPWT with Prontosan DEVICE

Negative pressure wound therapy with Prontosan irrigation.

Quantum™ Therapy/NPWT with Prontosan

Quantum™ Therapy DEVICE

Negative pressure wound therapy without irrigation.

Quantum™ Therapy

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of diabetes mellitus
• Men/women ≥21 years old
• Foot or ankle wounds sized 5 cm2 -100 cm2
• ABI≥0.5 or toe pressures \>30 mmHg

You may not qualify if:

• Active Charcot arthropathy
• Unable to use NPWT at home
• Untreated bone or soft tissue infection
• Unable to keep research appointments
• Active alcohol or substance abuse (\> 14 drinks per week over the last 3 months) or substance abuse (current use of cocaine, heroine or methamphetamine or if drug or alcohol use will interfere with follow up visits in foot clinic in the opinion of the investigator)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9132, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Lawrence A Lavery, DPM, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: December 4, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)