Key messages
• There is not enough evidence to know if any treatment helps to reduce injury to the remaining leg in amputees.
• More research is needed into treatments to prevent harm to the remaining leg in this group.
Why are amputations of the leg performed?
Amputations of the leg are commonly performed due to problems with the blood supply of the leg, typically because of diabetes or problems with the circulation caused by older age, smoking, high blood pressure, and high cholesterol. This is commonly referred to as 'dysvascularity'. Approximately 1 in 10 people who have a leg amputated go on to lose the other leg.
Why is the remaining leg important in people who have amputations?
The care of the remaining limb has been identified as a key priority research area by groups of healthcare professionals and patients, in particular preventing further injury to the limb, including ulcers, gangrene (death of tissue due to an infection or lack of blood flow), and amputation. However, little is known regarding treatments (educational, medical, psychological, behavioural) that reduce the risk of losing the remaining limb in people who have had an amputation. These treatments may involve reducing pressure on the limb to prevent ulcers, or improving blood flow in the remaining limb with the use of medication, thus preventing further episodes of ulcers or gangrene which lead to limb loss.
What did we want to find out?
We wanted to know if any treatment other than surgery can help preserve and protect the remaining limb. These include medicines; educational toolkits, which may include books, leaflets, and online courses for patient participation; dressings, arrangements of care for people at home; and changes to how organisations deliver care.
What did we do?
We searched for studies comparing any non-surgical treatment with any other non-surgical treatment or no treatment for preserving and protecting the remaining limb in leg amputees. We included studies that reported on injuries such as ulcers and gangrene or amputation of the remaining limb. We aimed to compare and summarise the results and rate our confidence in the evidence based on factors such as study methods and sizes.
What did we find?
We included one study that compared electrical stimulation therapy to the calf of the remaining leg plus usual rehabilitation versus usual rehabilitation alone after surgery in 50 people who had an amputation. This is an experimental technique that has not been widely practised or written about. The study found no new incidence of tissue loss and no difference between groups in overall survival of people, but those who had undergone electrical stimulation therapy were three times less likely to have an amputation (4% versus 12%). The study did not report on time to new tissue loss, amputation, or minor amputation, or on the incidence of minor amputation.
What are the limitations of the evidence?
We found only a single study. There were problems with how the study was conducted and reported. Importantly, there was no difference in the appearance of ulcers or gangrene, or pain in the limbs of those who took part in the study, so it is not clear why there was a difference in the amputation rate. We therefore have little confidence in the available evidence. Further research is needed.
How up-to-date is this evidence?
The evidence is current to March 2023.
Despite the care of the CLL being identified as a key research priority by two separate consensus papers, there is insufficient high-quality evidence to address this priority to date. We found only a single RCT suitable for inclusion, and this study was subject to risk of bias. Contralateral limb outcomes should be recorded in future research on dysvascular amputees. Until better evidence and clearer recommendations are available, this topic is likely to remain a research priority.
To assess the effects of non-surgical interventions versus placebo, no intervention, or other non-surgical interventions on contralateral limb (CLL) tissue loss and amputation in dysvascular patients with a primary major LLA.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PEDro databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers until 20 March 2023. We also checked the references of identified studies and contacted study authors and manufacturers of relevant products.
This Cochrane review had no dedicated funding.
Protocol available via DOI 10.1002/14651858.CD013857