WWIC Speckle study
Research type
Research Study
Full title
A single centre open label study measuring microcirculatory flux using Speckle imaging Device, in patients with Arterial, Mixed and Diabetic Foot Ulcers using geko™ neuromuscular electro stimulation device
IRAS ID
229471
Contact name
Marie-Therese Targett
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Research Summary
The geko device has been shown to increase lower limb blood flow in healthy volunteers by stimulating the peroneal nerve. This is not a painful process, your foot would twitch and a feeling rather like clenching and unclenching your calf muscle may be present. It is hoped that if similar increases in blood flow are observed in patients with a problem with blood flow in their lower limb(i.e with venous leg ulcers [VLU])then improvements in their condition may be possible.
This is a single centre study measuring circulation using Speckle imaging Device which is a camera which scans the leg to measure the flow of blood. Patients would be invited to attend for one appointment at the research facility in Llantrisant for approximately two hours.Summary of Results
Background: Neuromuscular electrical stimulator (NMES) devices increase blood flow to the lower limb by a process of intermittent muscular contraction initiated by a transdermal stimulus to the common peroneal nerve. However, its effects on localized microvascular blood supply to lower limb wounds are unknown. This study is a single-center open label study measuring the effect of neuromuscular stimulation of the common peroneal nerve on the microvascular blood flow within the wound bed of arterial leg ulcers, diabetic foot ulcers and mixed aetiology ulcers.
Methods: Twenty eight patients were enrolled. Eight with ischemic arterial wounds, 13 with diabetic foot wound and 8 with mixed aetiology wounds. All patients had an NMES (geko) applied to the common peroneal nerve. Baseline and intervention analysis of blood flow to the wound bed and edge was performed using Laser Speckle Contrast Imaging. Mean flow (flux) and pulse amplitude (pulsatility) were measured.
Results:
Arterial Leg Ulcers
Stimulation of the common peroneal nerve with the NMES resulted in a significantly increased flux and pulsatility in both the wound bed and the wound edge in all 8 patients. NMES increased wound bed flux by a mean of 64% (P=0.0005), and pulsatility by a mean of 452% (P = 0.004). Peri-wound area flux increased with use of the device by a mean of 37% (P=0.02), and pulsatility by a mean of 188% (P=0.002).Diabetic Foot Ulcers
In the 11 neuropathic ulcers, significant increases were seen in all microvascular parameters. Wound bed flux increased by 36% (95%CI 11%-68%, P=0.002), and peri-wound flux increased by 92% (95%CI 46%-160%, P=0.001). Pulsatility in the wound bed increased by 183% (95%CI 61%-517%, p=0.005), while pulsatility in the peri-wound increases by 359% (95%CI 264%-455%, P=0.001). Additionally, an increase in flux and pulsatility was observed in the neuroischemic ulcers.Mixed Aetiology Ulcers
When activated by NMES, wound bed flux increased by 38% (95%CI 11%-73%, P=0.023), and peri-wound flux increased by 19% (95%CI 9%-32%, P=0.009). Pulsatility in the wound bed increased by 214% (95%CI 51%-985%, P=0.017), while pulsatility in the peri-wound increased by 122% (95%CI 38%-299%, =0.014).Conclusions: Neuromuscular electrical stimulation immediately increases microcirculatory blood flow to the wound bed and edge in patients with lower limb wounds. These data may provide mechanistic insight into the clinical efficacy of NMES in healing wounds.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0292
Date of REC Opinion
29 Aug 2017
REC opinion
Favourable Opinion