At a glance
ClinicalIndex Comparison RecordN/ACompleted· 16 enrolled
Drug / intervention
NPWT System +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes.
In Brief
A clinical study evaluating NPWT System and NPWT system for Diabetes and Foot Ulcers. Completed, enrolled 16 participants across 2 sites.
Detailed Summary
Primary objective * To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives * To investigate the pain level at dressing removal * To visually check exudate removal * To investigate the ease of use for the subject and care giver when using the NPWT system
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Foot Ulcers
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2009
Enrollment StartJan 2010
Primary CompletionJul 2010
TodayJul 2026
First PostedNov 11, 2009
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.6 years ago
Interventions
NPWT Systemprocedure
Dressing change 3 times per week
NPWT systemdevice
3 dressing changes/week for maximum 4 weeks.