N/A
N=8
ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02211495 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Day Until 50% Healing of Leg Ulcer — 55; 30 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GEKO device (Device); Best Medical Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Day Until 50% Healing of Leg Ulcer |
55; 30 | — |
| SECONDARY Quality of Life (PAID, EQ5D, VAS, SF-12) |
22.8; 13; 21.2; 17.3; .54; .7 | — |
Summary
The investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes
Eligibility Criteria
Inclusion criteria
- 18+ years old
- Type 2 diabetes on best medical therapy
- Active foot ulceration, present <3 months Exclusion criteria
- Pregnancy
- Pacemaker
- Metal implants in the legs (below knee)
Data sourced from ClinicalTrials.gov (NCT02211495). 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.