Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03186560 |
| Other study ID # |
FSK-Speckle-001 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 12, 2018 |
| Est. completion date |
January 26, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Firstkind Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a single centre open label study measuring microcirculatory flux using Speckle
imaging Device.
Microcirculation will be measured using laser speckle contrast imaging, at baseline and with
the device active for 30 minutes in the wound, peri-wound and other point on the lower leg.
The same procedure will be done on all the different patient groups.
Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp
DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the
30 minutes activity of the device.
Description:
The most common underlying etiologic factors responsible for chronic delayed healing among
lower extremity wounds encountered in the outpatient clinic are chronic venous insufficiency
(CVI), diabetic neuropathy, and arterial insufficiency (AI). One or more of these factors can
be identified in more than 90% of chronic lower extremity ulcers, and treatment protocols
have been designed to manage wounds of each type to maximize healing potential. It is
important to remember that multiple factors may coexist in any individual patient with a
chronic wound, complicating management and hindering the healing process. Recently, it has
been reported that the neuroischemic diabetic foot ulcer is now more common than nonischemic
neuropathic diabetic foot ulcers, as arterial insufficiency promoted by poorly controlled
diabetes complicates already impaired healing present in patients with diabetes.
Chronic leg ulcers are painful, debilitating wounds that place a significant burden on the
patient, their family, and healthcare resources. Treating leg ulcers can present a
significant challenge to clinicians, who currently have a limited range of treatments at
their disposal. The mainstay of treatment is compression bandaging, ambulation and elevation
at rest. In patients with mobility deficits, or in those who are unable to tolerate
compression bandaging, ulcers may deteriorate and never heal. Accordingly, there is a need
for novel, alternative devices or strategies that can be used to complement or replace
compression therapy.
Numerous pathophysiological and metabolic factors can affect wound healing and result in a
poor outcome. They include local causes such as oedema, ischemia, tissue hypoxia, infection,
necrosis and growth factor imbalance, as well as systemic causes including metabolic disease,
nutritional status general perfusion disturbances and pre-existing illness. These factors
alter the wound repair environment, impede healing and increase the risk of chronic wound
development. All healing processes including, inflammatory cell influx, fibroblast migration,
and collagen and extracellular matrix deposition, are delayed in this situation, leading to
prolonged wound healing.
Any wound management should assist the healing process and optimise the patient's blood flow
to the wound area4. An acute wound in a stable patient with normal blood flow should heal
successfully. Anything that compromises tissue oxygen delivery, such as poor vascularisation,
will impede healing. There is a strong scientific basis for oxygen treatment as prophylaxis
against infection; to facilitate wound closure and to prevent amputation in wounded patients.
Oxygen delivery is a critical element for the healing of wounds. Hypoxemia, caused by
disrupted vasculature, is a key limiting factor against wound healing.
The link between compromised circulation and ulceration is well established and well
described. Chronic venous insufficiency is a direct cause of ulceration.
Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major
component of the diabetic foot. Diabetes mellitus is one such metabolic disorder that impedes
the normal steps of the wound healing process. Many studies show a prolonged inflammatory
phase in diabetic wounds, which causes a delay in the formation of mature granulation tissue
and a parallel reduction in wound tensile strength.
Treatment of diabetic foot ulcers should include: blood sugar control, removing dead tissue
from the wound, dressings, and removing pressure from the wound through techniques such as
total contact casting. Surgery in some cases may improve outcomes. Hyperbaric oxygen therapy
may also help but is expensive. It occurs in 15% of people with diabetes and precedes 84% of
all diabetes-related lower-leg amputations.
