N/A
Completed N=150
Negative Pressure Wound Therapy as a Drug Delivery System
Source: ClinicalTrials.gov NCT02463487 ↗Enrolled (actual)
150
Serious AEs
53.3%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound — 44; 45 Participants — p=0.87
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Achieved Complete Healing or Coverage of the Study Wound |
44; 45 | 0.87 |
| SECONDARY Total Adverse Events of Participants |
12; 18; 26; 27; 13; 14 | — |
| SECONDARY Number of Participants With Wound Dehiscence After Hospital Discharge |
46; 40 | 0.08 |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT02463487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.