ISRCTN77093550已完成未知
Intermittent Pneumatic Compression of the Thigh for the Treatment of lower limb wounds (IPCOTT): a randomised control trial of IPC plus standard care vs. standard care alone
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 31/01/2023 (updated 04/09/2023):
- •1. Age =18 years
- •2. Presence of at least one hard-to-heal*, venous or mixed (of both venous and arterial origin) aetiology lower limb wound
- •3. ABPI =0.6, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out significant peripheral arterial disease i.e. Doppler ausculation, toe pressure assessment (Absolute Toe Pressure =40mmHg ) or arterial imaging
- •4. Has received high static compression therapy (in the form of bandages, wraps or hosiery) during the preceding 4 weeks and is willing to continue receiving appropriate static compression therapy for their ulcer aetiology for the duration of the study
- •5. Receiving standard wound care as per investigator discretion which will continue regardless of study participation
- •6. Able and willing to give informed consent for participation in the study
- •7. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for 2 hours daily for a 16-week period
- •8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo a pregnancy test at screening
- •Previous inclusion criteria from 05/03/2021 to 04/09/2023:
- •1. Age =18 years
- •2. Presence of at least one lower limb wound with venous aetiology, which is hard to heal. For the purpose of this trial, hard to heal is defined as a failure of the wound to progress towards healing (as indicated by a decrease in surface area by =25%) in the preceding month, despite appropriate and adequate compression therapy.
- •3. ABPI = 0.8, or, where an ABPI measure is not viable, use of locally-approved alternative assessments to rule out peripheral arterial disease i.e. Doppler ausculation, toe pressure assessment (TBI > 0.5) or arterial imaging
- •4. Has received high static compression therapy (in the form of bandages, wraps, or hosiery) during the preceding 4 weeks and is willing to continue receiving high static compression therapy for the duration of the study
- •5. Able and willing to give informed consent for participation in the study
- •6. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16-week period
- •Previous inclusion criteria:
- •1. Age =18 years
- •2. Presence of at least one lower limb wound with venous aetiology, which is hard to heal. For the purpose of this trial, hard to heal is defined as a failure of the wound to progress towards healing (as indicated by a decrease in surface area by =25%) in preceding month, despite appropriate and adequate compression therapy.
- •3. Has received high static compression therapy (in the form of bandages, wraps, or hosiery) during the preceding 4 weeks and is willing to continue receiving high static compression therapy for the duration of the study
- •4. Able and willing to give informed consent for participation in the study
- •5. Able to self-apply IPC garment (supplied) and connect to an electrically operated pump at home for two hours daily for a 16-week period
排除标准
- •Current exclusion criteria as of 31/01/2023 (updated 04/09/2023):
- •1. Wound surface area =100cm²
- •2. Wound duration =2 months or = 5 years
- •3. Diabetic patients with recentI HbA1c >8.5
- •4. Known or suspected deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis
- •and acute infections of the skin, such as cellulitis
- •5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema or any condition where an increase of fluid to the heart may be detrimental
- •6. Severe arteriosclerosis or other ischaemic vascular disease
- •7. Leg ulcers without a venous component to their aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates compression (ABI < 0.6 or Absolute Toe Pressure <40 mmHg)
- •8. Known malignancy
- •9. Patient receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
- •10. Current participation in any other clinical trial
- •11. Patient likely to miss more than 5 days of therapy (e.g. for planned holiday)
- •12. Thigh circumference >90 cm (maximum garment size)
- •13. Any wounds, infection or dermatological conditions that would be adversely affected by placement of the thigh garment
- •14. Subject is pregnant or breastfeeding
- •Previous exclusion criteria from 05/03/2021 to 04/09/2023:
- •1. Wound surface area =100 cm²
- •2. Wound duration =2 months or =5 years
- •3. Diabetic patients with recent HbA1c >8.5
- •4. Known, or suspected, deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis, or acute infections of the skin, such as cellulitis
- •5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema, or any condition where an increase of fluid to the heart may be detrimental
- •6. Severe arteriosclerosis or other ischaemic vascular diseases
- •7. Leg ulcers of non-venous aetiology (e.g., arterial or rheumatoid) or significant peripheral vascular disease which contraindicates full compression (ABPI < 0.8 or TBI = 0.5)
- •8. Known malignancy
- •9. Receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
- •10. Current participation in any other clinical trial
- •11. Likely to miss more than five days of therapy (e.g. for planned holiday)
- •12. Thigh circumference >73 cm (maximum garment size)
- •Previous exclusion criteria:
- •1. Wound surface area =100 cm²
- •2. Wound duration =2 months or =5 years
- •3. Diabetic patients with recent HbA1c >8.5
- •4. Known, or suspected, deep vein thrombosis (DVT), pulmonary embolism, thrombophlebitis, or acute infections of the skin, such as cellulitis
- •5. Decompensated/severe congestive cardiac failure, pulmonary oedema associated with significant limb oedema, or any condition where an increase of fluid to the heart may be detrimental
- •6. Severe arteriosclerosis or other ischaemic vascular diseases
- •7. ABPI =0.8 or =1.3
- •8. Known malignancy
- •9. Receiving any other adjunctive wound therapy such as heat, topical negative therapy, biotherapy
- •10. Current participation in any other clinical trial
- •11. Likely to miss more than five days of therapy (e.g. for planned holiday)
- •12. Thigh circumference >73 cm (maximum garment size)
研究者
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