A Pilot Randomised Control Trial to Measure the Effectiveness of Combined Modulated Ultrasound and Electric Current Stimulation in Treating Diabetic Foot Ulcers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Total wound healing
研究概览
简要总结
The study aims to investigate if combined modulated ultrasound and electric current stimulation (CUSECS) is an effective adjunctive treatment to use to treat diabetic foot ulcers when compared against usual care. Consenting patients with diabetic foot ulcers (DFUS) and meet the inclusion criteria will be randomly allocated in to either an experimental group or a control group. The experimental group will receive the adjunctive CUSECS treatment along their usual treatment for their diabetic ulcer. They will be required to attend the Diabetic Foot clinic in St. James's hospital twice a week for a maximum of eight weeks. The CUSECS is provided by attaching small electrodes around the ulcers to provide electric current stimulation. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing. The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer once a week for a maximum for eight weeks. Once a week both groups ulcers will be assessed and measured and a photograph solely of the wound will be taken for documentation of wound healing. Wound pain as determined using the 0-10 Numeric pain rating scale will also be measured once a week.
The movement in participant's ankle will be measured (flexion, extension, inversion) at the start and at the end of the study to see if treatment has improved its movement.
As part of this study participants' will also be requested to fill out a SF-36 questionnaire at the start and at the end of the 8 week trial. This questionnaire evaluates a person's health related quality of life in which the research wants to see if it is affected by a diabetic foot ulcer. The self-efficacy of participants will also be assessed using PROMIS® Item Bank v.1.0 - General Self-Efficacy at the start and at the end of the 8 week trial. The cost of treatment for each arm will be calculated taking into account both direct (cost of treatments, consumables etc.) and indirect costs (loss of earnings, travel, parking etc.). Therefore, as part of this study, participants will be asked about mode of transport and transport time to and from the clinic and if their diabetic foot ulcer has affected their ability to work.
Diabetic foot ulcer reoccurrence rates will be monitored in both groups by a follow up appointment 4 weeks after each group completes treatment or monitoring.
Data from both groups will be examined and compared to see if CUSECS is effective in healing DFUs. The primary outcome of interest is wound healing and is determined by the number of wounds healed and the time to complete wound healing within eight weeks. All data will be stored confidentially.
The study hypothesis is that there is be increased healing rates in subjects treated with CUSECS in combination with standard care compared to those treated with standard care alone.
This study aims to provide evidence for continuing improvement in treatment for those suffering with diabetic foot ulcers.
详细描述
Study Background:
Diabetes is predicted to be one of the greatest challenges for individuals and society as a whole into the future. Persons with diabetes are 50 times more likely to develop a foot ulcer than their non-diabetic counterparts (1). The prevalence of foot ulceration in this patient group is suggested to range from 3-10 %(1). These wounds are difficult to heal and this is often compounded by the presence of multiple co-morbidities. Furthermore, diabetes is the leading cause of non-traumatic limb amputation in the world (2). Within 18 months following amputation, almost 50 percent of these people will develop ulceration on the other limb and of these, 58% will have further amputations within three to five years(3). It is worthy of note that the three-year mortality rate after the first amputation is between 20 and 50 percent (4, 5). Having diabetes impacts negatively on the individuals' heath related quality of life when compared to the general population (6). The most important variable influencing changes in HRQOL is the presence of complications of diabetes. Having a foot ulcer causes a loss of mobility for the individual thereby decreasing social functioning. Furthermore almost 50% of people will suffer with intractable pain (6).
The International Working Group of the Diabetic Foot (IWGDF) highlight the continuing difficulties in selecting clinically effective treatments for diabetic foot infection and ulceration. In two commissioned systematic reviews they point to the large number of treatment options available while at the same time the relative weakness of evidence to support the use of many of these options (7, 8). Two of these treatments, electrostimulation and ultrasound, were utilised in this study. While both these technologies have been shown to be effective in chronic wound healing, the use of combined modulated ultrasound and electrical current stimulation (CUSECS) is a new and not widely studied treatment Avrahami (9). The merits of each treatment individually will be explored below.
Widespread interest and research into the use of electrostimulation is evident since the 1960s (10). Electrostimulation has been shown to have an effect on a range of mechanisms which are beneficial to wound healing including;
- Improvement of blood flow
- Improvement in tensile strength
- Stimulation of protein and DNA synthesis
- Reductions in oedema
- Decreased bacterial growth
- Promotion of epithelial, fibroblast, neutrophil and macrophage cells
- Reduction in pain. (11,12)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Analysis of data will be blinded and carried out by a statistician. Patient data will be coded and not identifiable directly. The key to the code book information will be secured separately from the dataset in an encrypted file, which will only be accessible by the researcher and the supervisors of the study. Therefore the each arm will be coded and none identifiable to the outcome assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be a diagnosed diabetic.
- •Participants who have the capacity to provide informed consent prior to participation in the study.
- •Participants must be aged 18 or over on the day of the informed consent.
- •Participants have an ulcer that has been present for at least 60 and less than 365 days.
- •Participants and/or caregiver must be willing and able to comply with all study procedures and scheduled follow-up visits, for the duration of the study.
排除标准
- •Subjects without capacity to consent or those who do not provide informed consent.
- •Ulcers that have a total surface area greater than 15 cm2 as measured by a member of the study staff.
- •Unwilling to continue with their standard wound care therapy for the study duration.
- •Clinical evidence of infection or gangrene on any part of the affected foot or leg. A subject with clinically infected wound(s) who otherwise meets the study criteria may enter the study after successful treatment of the for wound infection.
- •Target ulcer involving exposure of tendon, bone or joint capsule, or any tunnelling or sinus tracts (it is acceptable to have ulcers extending through the dermis and into subcutaneous tissue with presence of granulation tissue).
- •Target ulcer treatment with a wound dressing containing human growth factors, engineering tissues, or skin substitutes (e.g. Apligraf, Dermagraf, Regranex etc) within 30 days of screening visit or planned during the study duration.
- •History of bone cancer or metastatic disease of the affected limb, radiation therapy to the affected limb, or chemotherapy within the 12 months prior to screening visit.
- •Suspected or confirmed malignancy of the wound.
- •Participation in another drug or device study for the treatment of diabetic foot ulcer within 30 days of screening visit.
- •Vascular procedures performed within 30 days of screening visit.
- •Active bleeding tissue or untreated haemorrhagic conditions.
- •Active or suspected DVT or thrombophlebitis.
- •Conditions which, in the judgment of the treating investigator, may severely compromise the subject's ability to complete the study.
研究组 & 干预措施
Control group
The control group will be required to attend the diabetic foot clinic for their usual care for their diabetic foot ulcer with weekly review for a maximum of eight weeks. They will also have a follow up appointment 4 weeks after completion of treatment.
Experimental Arm
A device- BRH-A2 wound healing device will provide Combined ultrasound and electric current stimulation (CUSECS) treatment which is the intervention for this arm. Participants in this group will receive an adjunctive combined ultrasound and electric current stimulation (CUSECS) treatment along their usual treatment for their diabetic ulcer twice weekly for 8 weeks using the BRH-A2 wound healing device. They will also have a follow up appointment 4 weeks after completion of treatment.
干预措施: BRH-A2 wound healing device (Device)
结局指标
主要结局
Total wound healing
时间窗: 8 weeks
The number of wounds that completely heal in the experimental group compared to control group. This may be presented in either or both following formats: * The proportion of wounds completely healed (frequency of complete healing by group). * The time to complete wound healing.
次要结局
- Cost of treatment per arm (economic analysis direct cost and in-direct costs).(8 weeks)
- Self-efficacy(8 weeks)
- Changes in wound bed condition.(8 weeks)
- Diabetic foot ulcer reoccurrence rates(4 weeks after the treatment trial is completed (16 weeks))
- Ankle Range of Motion(8 weeks)
- Patient reported quality of life(8 weeks)
- Wound pain(8 weeks)