Wound Healing, Leg and Foot Ulcers, Macrocirculation, Microcirculation Clinical Trial
Official title:
Acute and Long-term Clinical Effects of Intermittent Negative Pressure on Wound Healing in Spinal Cord and the Peripheral Circulation in Spinal Cord Injured Subjects
| Verified date | September 2017 |
| Source | Oslo University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a pilot study to evaluate the treatment effect of INP on wound healing and tissue
perfusion for a larger randomized controlled trial (RCT). This randomized cross-over pilot
study will look at the effects of intermittent negative pressure (INP) therapy wound healing
and the peripheral macro- and microcirculation in spinal cord injured patients with chronic
leg and foot ulcers (6 weeks or more at inclusion). The project is designed as a randomized
clinical trial with single-subject multiple baseline design. We will perform convenience
sampling of spinal cord injured patients with leg and foot ulcers, with the last recruitment
by the end of december 2016.To ensure equal distribution of participants in each study arm,
we will perform block randomization. A statistician will randomized patients to either
intervention arm or control arm before start of the study: At baseline, each participants
will be randomized into either A) 8 weeks without intervention OR B) 8 weeks with start INP
therapy 2 hours per day divided into 2-3 timed sections. After the 8 weeks, participants in
the the control group (A) will be re-examined, and start 8-week INP therapy. Also the
intervention (INP) will be subjected to the same lower limb in each individual throughout the
study period. The other leg will act as a intra-individual control.
At baseline (week 0), and during the course of the study (every 4th week), the participants'
wounds will be measured by a wound nurse. Baseline (before start of INP therapy) and after
intervention the following measures will be performed: Demographic data (weight, height,
ABI), Segmental pulse-volume-recording, Segmental skin perfusion pressure with a laser
Doppler sensor and a pressure cuff to evaluate reactive hyperemia (Sensilase, Väsamed) and
health surveys (SF-36/EQ-5D-5L and customized wound questionnaire) or similar will be
examined at baseline and and the end of the study period. Otivio AS has supplied the FlowOx
devices and provided the necessary training to perform this project. Outcome variables
assessed before and after the study period will be: wound healing (primary endpoint), quality
of life (secondary endpoint), skin perfusion pressure (secondary endpoint), ankle-brachial
pressure (secondary endpoint) and segmental pulse-volume recording (secondary endpoint). The
aim of this project is to prospectively examine and elucidate the effect of intermittent
negative pressure therapy applied to a limited part of the lower limb on clinically relevant
measures related to wound healing and peripheral macro- and microcirculation in patients with
spinal cord injury.
The hypotheses of the study are:
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve wound healing in the foot compared to before treatment (baseline)
and compared to standard wound care alone.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve macro- and microcirculation in the foot compared to before
treatment (baseline) and compared to standard wound care alone in patients with spinal
cord injury.
- Application of INP in patients with spinal cord injury, by the use of the FlowOx™
device, will improve macro- and microcirculation in the intervention foot compared to
the control foot and compared to standard wound care alone in patients with spinal cord
injury.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | April 20, 2017 |
| Est. primary completion date | April 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 96 Years |
| Eligibility |
We will perform convenience sampling of spinal cord injured patients with leg ulcers,
recruited through health professionals affiliated with Sunnaas Rehabilitation hospital. Inclusion Criteria: - Able and willing to provide informed consent - Age: 18-96 years - Affected foot/shoe size <46 (approximate foot length< 29,5 cm) - Spinal cord injury preferably with a non-healing leg/foot ulcer/pressure wound for more than 6 weeks Exclusion Criteria: - Incapable to consent voluntarily, i.e. patients who are not able to consent due to their mental status, or who are not willing or able to perform the negative pressure therapy in a sitting position - Not adhering to the INP therapy program - Patients with an expected life-span less than 3 months - Patients in which a deep venous thrombosis or pulmonary embolism is suspected - Bilateral amputation of lower extremity |
| Country | Name | City | State |
|---|---|---|---|
| Norway | Sunnaas Rehabilitation Hospital | Nesodden | Akershus |
| Lead Sponsor | Collaborator |
|---|---|
| Oslo University Hospital | Otivio AS |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy | Measurement of healing to provide a means by which progress over time to wound closure can be identified. A wound nurse will take pictures at study start and at follow-up. Photographs will be measured and analysed using the ImageJ software. Reference: Schneider, C. A.; Rasband, W. S. & Eliceiri, K. W. (2012), "NIH Image to ImageJ: 25 years of image analysis", Nature methods 9(7): 671-675, PMID 22930834 | 16 weeks (baseline and after 8 and 16 weeks | |
| Primary | Photographic wound assessment tool, PWAT 0-24 score | PWAT is wound assessing tool consisting of 6 domains that assess the composition of the wound bed and viability of the wound edge and periulcer skin that are capable of being viewed using a wound photograph. hese six domains include wound edges, necrotic tissue type and amount, skin color surrounding wound, granulation tissue type, and epithelialization. Scores assigned on a scale of 0 to 4 to each of the domains of the PWAT are summed to derive a total PWAT score between 0 and 24, with zero representing a completely healed ulcer. Reference: Houghton PE, Kincaid CB, Campbell KE, et al. Photographic assessment of the appearance of chronic pressure and leg ulcers. Ostomy/Wound Management. 2000;46(4):20-30 | 16 weeks (baseline and after 8 and 16 weeks | |
| Secondary | Change in Quality of life (SF-36 ) after 8 weeks of control and after 8 weeks of INP therapy | 16 weeks (8 weeks intervention+8 weeks control) | ||
| Secondary | Change in Segmental Skin Perfusion Pressure (SPP) after 8 weeks of control and after 8 weeks of INP therapy | Multiple levels can be assessed on limbs; bilateral measurement helps to manage test time. Not susceptible to interference effects from medial calcification Requires use of pressure cuffs to occlude blood flow for specified time period in order to evaluate reactive hyperemic response to controlled release of pressure. Graphical output of pressure and perfusion during cuff deflation indicates the pressure (mmHg) at which skin perfusion is found to return in addition to pressure contour. | 16 weeks (8 weeks intervention+8 weeks control) | |
| Secondary | Change in Pulse Volume Recording (PVR) after 8 weeks of control and after 8 weeks of INP therapy | PVR shows variations in the volume of blood passing through a limb during each cardiac cycle. The instrument that will be used to measure PVR for this study is Sensilase (Vasamed, USA) OR MacroLab (STR Teknikk, strteknikk.no, Aalesund, Norway). Multiple levels can be assessed on limbs. The measures are not susceptible to interference effects from medial calcification. |
16 weeks (8 weeks intervention+8 weeks control) | |
| Secondary | Change in Ankle-Brachial Pressure Index (ABPI) after 8 weeks of control and after 8 weeks of INP therapy | The ratio of the blood pressure at the ankle (dorsal pedis artery/posterior tibial artery) to the blood pressure in the upper arm (brachial artery) | 16 weeks (8 weeks intervention+8 weeks control) | |
| Secondary | Change in Quality of life (EQ-5D-5L) ) after 8 weeks of control and after 8 weeks of INP therapy | 16 weeks (8 weeks intervention+8 weeks control) |