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Stem Cell Research & Therapy Jul 2019The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing "minor" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care.
METHODS
In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain.
RESULTS
At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups.
CONCLUSION
The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).
Topics: Adipose Tissue; Aged; Aged, 80 and over; Amputation, Surgical; Diabetic Foot; Female; Humans; Male; Middle Aged; Transplantation, Autologous; Treatment Outcome
PubMed: 31358046
DOI: 10.1186/s13287-019-1328-4 -
Sensors (Basel, Switzerland) Jul 2016The distribution of interface stresses between the residual limb and prosthetic socket of a transtibial amputee has been considered as a direct indicator of the socket... (Review)
Review
The distribution of interface stresses between the residual limb and prosthetic socket of a transtibial amputee has been considered as a direct indicator of the socket quality fit and comfort. Therefore, researchers have been very interested in quantifying these interface stresses in order to evaluate the extent of any potential damage caused by the socket to the residual limb tissues. During the past 50 years a variety of measurement techniques have been employed in an effort to identify sites of excessive stresses which may lead to skin breakdown, compare stress distributions in various socket designs, and evaluate interface cushioning and suspension systems, among others. The outcomes of such measurement techniques have contributed to improving the design and fitting of transtibial sockets. This article aims to review the operating principles, advantages, and disadvantages of conventional and emerging techniques used for interface stress measurements inside transtibial sockets. It also reviews and discusses the evolution of different socket concepts and interface stress investigations conducted in the past five decades, providing valuable insights into the latest trends in socket designs and the crucial considerations for effective stress measurement tools that lead to a functional prosthetic socket.
Topics: Amputation Stumps; Amputees; Artificial Limbs; Biomechanical Phenomena; Humans; Prosthesis Design; Stress, Mechanical
PubMed: 27447646
DOI: 10.3390/s16071119 -
Frontiers in Molecular Neuroscience 2022The disordered growth of nerve stumps after amputation leading to the formation of neuromas is an important cause of postoperative pain in amputees. This severely...
OBJECTIVE
The disordered growth of nerve stumps after amputation leading to the formation of neuromas is an important cause of postoperative pain in amputees. This severely affects the patients' quality of life. Regenerative peripheral nerve interfaces (RPNIs) are an emerging method for neuroma prevention, but its postoperative nerve growth and pathological changes are yet to be studied.
METHODS
The rat sciatic nerve transection model was used to study the effectiveness of RPNI in this experiment. The RPNI (experimental) group ( = 11) underwent RPNI implantation after sciatic nerve transection, while the control group ( = 11) only underwent sciatic nerve transection. Autotomy behavior, ultrasonography, and histopathology were observed for 2 months postoperatively.
RESULTS
Compared to the control group, the incidence and size of the neuromas formed and the incidence and extent of autotomy were significantly reduced in the RPNI group. The axon density in the stump and degree of stump fibrosis were also significantly reduced in the RPNI group.
CONCLUSION
RPNI effectively prevented the formation of neuromas.
PubMed: 35875668
DOI: 10.3389/fnmol.2022.938930 -
Journal of Reconstructive Microsurgery Nov 2022The treatment of painful neuroma remains challenging. Recently, a nerve-end capping technique using a bioabsorbable nerve conduit was newly introduced to treat...
BACKGROUND
The treatment of painful neuroma remains challenging. Recently, a nerve-end capping technique using a bioabsorbable nerve conduit was newly introduced to treat amputation neuroma. A collagen-coated polyglycolic acid (PGA) conduit has been commercially available for the reconstruction of peripheral nerve defects, yielding successful clinical outcomes. However, no experimental research has been conducted using this PGA nerve conduit as capping device for treating amputation neuroma. The purpose of this study was to investigate nerve-end capping treatment with the PGA conduit in the rat sciatic nerve amputation model, focusing on histological scar formation and neuroinflammation.
METHODS
Forty-seven rats were divided into two groups: no capping (transected nerve stump without capping; = 25) and capping (nerve-end capping with collagen-coated PGA nerve conduit; = 22). Twelve weeks after sciatic neurectomy, neuropathic pain was evaluated using the autotomy score. Stump neuromas were histologically evaluated or perineural scar and neuroinflammation.
RESULTS
While autotomy scores gradually exacerbated in both groups, they were consistently lower in the capping group at 4, 8, and 12 weeks postprocedure. Twelve weeks after surgery, the transected nerve stumps in the no-capping group had formed macroscopic bulbous neuromas strongly adhering to surrounding tissues, whereas they remained wrapped with the PGA nerve conduits loosely adhering to surrounding tissues in the capping group. Histologically, distal axonal fibers were expanded radially and formed neuromas in the no-capping group, while they were terminated within the PGA conduit in the capping group. Perineural scars and neuroinflammation were widely found surrounding the randomly sprouting nerve end in the no-capping group. In capped counterparts, scars and inflammation were limited to closely around the terminated nerve end.
CONCLUSION
Nerve-end capping with a collagen-coated PGA conduit after rat sciatic neurectomy might prevent neuroma formation by suppressing perineural scar formation and neuroinflammation around the nerve stump, potentially relieving neuropathic pain.
Topics: Animals; Rats; Cicatrix; Collagen; Nerve Regeneration; Neuralgia; Neuroma; Polyglycolic Acid; Sciatic Nerve
PubMed: 36122572
DOI: 10.1055/s-0042-1757208 -
European Journal of Vascular and... Jun 2009Major limb amputation is often required by patients with a limited capacity to tolerate post-operative complications. Amputation stump infection is common and may... (Review)
Review
BACKGROUND
Major limb amputation is often required by patients with a limited capacity to tolerate post-operative complications. Amputation stump infection is common and may necessitate re-amputation, potentially exposing a vulnerable patient to further serious complications. Effective antibiotic strategies should be employed to reduce wound infection after major amputation.
METHODS
Online databases were searched to identify studies regarding reduction in wound infection following major limb amputation. Only four randomised studies were identified comparing antibiotic prophylaxis with control; a further three evaluated the efficacy of specific antibiotics. Study design, end-points and outcome data were recorded. The data were too heterogeneous for formal meta-analysis.
RESULTS
Prophylactic antibiotics significantly reduced rates of stump infection in all studies, and were associated with a reduced rate of re-amputation in one. Where investigated, the type of antibiotic did not affect rates of infection. In non-randomised studies, infection with methicillin resistant Staphylococcus aureus (MRSA) increased the risk of complications and post-operative death.
CONCLUSION
It is agreed that prophylactic antibiotics are part of the standard of care for amputation surgery, and this is supported by limited, mostly historical-controlled data. Evolution of the bacterial threat means that future studies should assess the role and type of prophylaxis for patients with existing bacterial colonisation or infection.
Topics: Amputation, Surgical; Amputation Stumps; Antibiotic Prophylaxis; Humans; Methicillin-Resistant Staphylococcus aureus; Reoperation; Surgical Wound Infection; Treatment Outcome; Wound Healing
PubMed: 19328028
DOI: 10.1016/j.ejvs.2009.01.013 -
IScience Feb 2022Zebrafish regenerate fin rays following amputation through epimorphic regeneration, a process that has been proposed to involve the epithelial-to-mesenchymal transition...
Zebrafish regenerate fin rays following amputation through epimorphic regeneration, a process that has been proposed to involve the epithelial-to-mesenchymal transition (EMT). We performed single-cell RNA sequencing (scRNA-seq) to elucidate osteoblastic transcriptional programs during zebrafish caudal fin regeneration. We show that osteoprogenitors are enriched with components associated with EMT and its reverse, mesenchymal-to-epithelial transition (MET), and provide evidence that the EMT markers and are co-expressed in dedifferentiating cells at the amputation stump at 1 dpa, and in differentiating osteoblastic cells in the regenerate, the latter of which are enriched in EMT signatures. We also show that , a regulator of alternative splicing in epithelial cells that is associated with MET, is expressed in a subset of osteoprogenitors during outgrowth. This study provides a single cell resource for the study of osteoblastic cells during zebrafish fin regeneration, and supports the contribution of MET- and EMT-associated components to this process.
PubMed: 35169687
DOI: 10.1016/j.isci.2022.103784 -
Fukushima Journal of Medical Science Apr 2024In foot amputation, Chopart amputation is considered to have a high risk of deformity, and can result in poor function. We experienced a case in which Chopart amputation...
BACKGROUND
In foot amputation, Chopart amputation is considered to have a high risk of deformity, and can result in poor function. We experienced a case in which Chopart amputation combined with tendon transfer and tendon lengthening was performed, and the patient was eventually able to walk independently with a foot prosthesis without experiencing deformity of the foot. We investigated walking speed and plantar pressure after Chopart amputation with and without a foot prosthesis.
CASE
A 78-year-old man underwent Chopart amputation with tendon transfer and tendon lengthening. As a result, he was able to stand up and walk, both while bearing weight on the heel of the affected foot, but he was unable to push off the ground using that foot. When a foot prosthesis was introduced, the patient's walking speed increased from 0.6 m/s without the prosthesis to 0.8 m/s with the prosthesis, which was an increase of 33%. The plantar pressure at the stump decreased from 129.3 N/cm on average without the prosthesis to 51.6 N/cm with the prosthesis, which was a 59% decrease. Wearing a foot prosthesis improved the patient's walking speed and decreased plantar pressure at the amputation stump.
Topics: Humans; Male; Aged; Pressure; Amputation, Surgical; Foot; Walking Speed; Artificial Limbs; Walking
PubMed: 38494732
DOI: 10.5387/fms.23-00003 -
Journal of Rehabilitation Research and... 2013Advances in robotic technology have recently enabled the development of powered lower-limb prosthetic limbs. A major hurdle in developing commercially successful powered...
Advances in robotic technology have recently enabled the development of powered lower-limb prosthetic limbs. A major hurdle in developing commercially successful powered prostheses is the control interface. Myoelectric signals are one way for prosthetic users to provide feedforward volitional control of prosthesis mechanics. The goal of this study was to assess motor learning in people with lower-limb amputation using proportional myoelectric control from residual-limb muscles. We examined individuals with transtibial amputation and nondisabled controls performing tracking tasks of a virtual object. We assessed how quickly the individuals with amputation improved their performance and whether years since amputation correlated with performance. At the beginning of training, subjects with amputation performed much worse than control subjects. By the end of a short training period, tracking error did not significantly differ between subjects with amputation and nondisabled subjects. Initial but not final performance correlated significantly with time since amputation. This study demonstrates that although subjects with amputation may initially have poor volitional control of their residual lower-limb muscles, training can substantially improve their volitional control. These findings are encouraging for the future use of proportional myoelectric control of powered lower-limb prostheses.
Topics: Adolescent; Adult; Amputation, Surgical; Amputation Stumps; Artificial Limbs; Child; Female; Humans; Learning; Leg; Male; Middle Aged; Movement; Muscle, Skeletal; Psychomotor Performance; Robotics; Signal Processing, Computer-Assisted; Volition; Young Adult
PubMed: 24013916
DOI: 10.1682/jrrd.2012.06.0115 -
Der Unfallchirurg Dec 2020Soft tissue reconstruction in aged patients is challenging. Free tissue transfer can be carried out in healthy patients with a high success rate despite old age. When... (Review)
Review
BACKGROUND
Soft tissue reconstruction in aged patients is challenging. Free tissue transfer can be carried out in healthy patients with a high success rate despite old age. When free tissue transfer is contraindicated in multimorbid patients, local flaps are often chosen, which are associated with a high complication rate. Such salvage interventions must be selected so that an amputation is not disadvantageously influenced by the selection of the donor site or is even impossible.
METHODS
The three distally based local flaps the sural artery flap, peroneus brevis muscle flap and perforator-based propeller flaps are discussed with respect to placement of the donor site as well as wound healing disorders.
RESULTS
The sural artery flap is disadvantageous as the donor site because the proximal dorsal calf region is affected, which in the case of a below the knee amputation enables soft tissue covering of the stump.
CONCLUSION
If a local flap is to be used as a salvage surgery in an attempt to prevent a below the knee amputation in a patient who is not suitable for free tissue transfer, special emphasis must be placed on the donor site of this flap. The proximal dorsal aspects of the distal calf are required for covering a potential stump and should not be violated by harvesting a local flap.
Topics: Amputation, Surgical; Humans; Leg; Perforator Flap; Plastic Surgery Procedures; Soft Tissue Injuries; Surgical Flaps; Treatment Outcome
PubMed: 32385537
DOI: 10.1007/s00113-020-00814-6 -
Sensors (Basel, Switzerland) Jul 2021Sensor systems to measure pressure at the stump-socket interface of transfemoral amputees are receiving increasing attention as they allow monitoring to evaluate patient... (Review)
Review
Sensor systems to measure pressure at the stump-socket interface of transfemoral amputees are receiving increasing attention as they allow monitoring to evaluate patient comfort and socket fit. However, transfemoral amputees have many unique characteristics, and it is unclear whether existing research on sensor systems take these sufficiently into account or if it is conducted in ways likely to lead to substantial breakthroughs. This investigation addresses these concerns through a scoping review to profile research regarding sensors in transfemoral sockets with the aim of advancing and improving prosthetic socket design, comfort and fit for transfemoral amputees. Publications found from searching four scientific databases were screened, and 17 papers were found relating to the aim of this review. After quality assessment, 12 articles were finally selected for analysis. Three main contributions are provided: a de facto methodology for experimental studies on the implications of intra-socket pressure sensor use for transfemoral amputees; the suggestion that associated sensor design breakthroughs would be more likely if pressure sensors were developed in close combination with other types of sensors and in closer cooperation with those in possession of an in-depth domain knowledge in prosthetics; and that this research would be facilitated by increased interdisciplinary cooperation and open research data generation.
Topics: Amputation Stumps; Amputees; Artificial Limbs; Humans; Prosthesis Design; Walking
PubMed: 34372253
DOI: 10.3390/s21155016