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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two experienced outcome assessors/outcome adjudicators (certified wound nurse or physician or wound trained health care specialist) will assess the wound photographs using Photographic wound assessment tool (PWAT 0-24 score). At least one of the PWAT assessors will be blinded to the study group's assignments, and will not be involved in the study otherwise (intervention or in the standard wound care).
入排标准
- 年龄范围
- 18 Years 至 96 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intermittent negative pressure (INP) therapy
At baseline, the participants will be randomized into 2 groups: 1) INP therapy or 2) control with no INP therapy.
The 1) patients randomized to INP therapy will start with 8 weeks INP therapy two hours per day divided into timed sections (1-3 times per day or use the device as many times as practical for the individual as long as the total time is two hours). After 8 weeks of INP therapy, final measures will be performed at the Vascular lab before the participants starts their 8-week control period.
干预措施: Intermittent negative pressure device (Device)
Control
The participants randomized to control will continue their usual wound care for 8 weeks without INP therapy. The control group will start INP therapy after 8 weeks. After 8-weeks without intervention, the participants allocated to the control-group will be asked to start with INP therapy for 8 weeks before a final examination. The participants in the control group will receive vascular assesment at baseline, week 8 (end of control).
结局指标
主要结局
Percentage change in wound healing after 8 weeks of control and after 8 weeks of INP therapy
时间窗: 16 weeks (baseline and after 8 and 16 weeks
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
Photographic wound assessment tool, PWAT 0-24 score
时间窗: 16 weeks (baseline and after 8 and 16 weeks
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
次要结局
- 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))
- Change in Segmental Skin Perfusion Pressure (SPP) after 8 weeks of control and after 8 weeks of INP therapy(16 weeks (8 weeks intervention+8 weeks control))
- Change in Pulse Volume Recording (PVR) after 8 weeks of control and after 8 weeks of INP therapy(16 weeks (8 weeks intervention+8 weeks control))
- Change in Ankle-Brachial Pressure Index (ABPI) after 8 weeks of control and after 8 weeks of INP therapy(16 weeks (8 weeks intervention+8 weeks control))
- 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))
研究者
Jonny Hisdal
Dr. Jonny Hisdal
Oslo University Hospital
