Diabetic FootMetaMetNCT05804565
MetaMet: Bone Cutter Versus Bone Saw for Ray Amputation
A study testing Bone Saw and Bone Cutter in people with Diabetic Foot and Gangrene; Limb, run by University College Hospital Galway at 1 site in Ireland.
Trial summary
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Gangrene; Limb, Wound Infection
- What is being tested?
- Bone Saw and Bone Cutter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients, aged 18 and over, undergoing transmetatarsal amputation of one-to-two adjacent toes
Who cannot join
- Significant peripheral arterial disease, as defined by ABPI <0.4 or digital pressures of <50mmHg, not undergoing concurrent revascularisation;
- Patients undergoing amputation of three of more adjacent toes
- Patients unfit for surgery;
- Patients unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University College Hospital Galway
Galway, H91 YR71
Stewart R Walsh, FRCS, 871421564 ext. 00353, stewartredmond.walsh@universityofgalway.ie
About this study
Official title: Randomised Controlled Trial Comparing Metatarsal Method of Transection Using Bone Cutters or Bone Saw on Outcomes After Ray Amputation (MetaMet)
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut.
For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen.
Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.
Read the detailed description
Toe amputation is a common minor vascular procedure and is increasingly performed in the context of irretrievable diabetic foot infection, with and without concurrent ischaemia. Approximately 422 million people worldwide have diabetes mellitus and peripheral arterial disease (PAD) affects approximately 200 million people(1). The intersection between diabetes, neuro-ischaemic foot ulceration and lower limb amputations is well established(2). Recently published data from the United States reported overall rates of lower limb amputations in diabetic patients rose between 2000 and 2015, in part due to a 62% increase in the rate of minor (foot and toe) amputations(3). It is estimated that 6% of Irish adults are diabetic; from this, we can extrapolate the burden of managing diabetic foot complications(4). Resource utilisation notwithstanding, the financial costs of managing diabetic foot complications are estimated to outstrip some cancers(5). As the prevalence of diabetes mellitus rises amongst an ageing Irish population, the importance of achieving durable functional outcomes after partial foot amputation is paramount.
Re-ulceration, re-infection, re-amputation and hospital re-admission after partial foot amputation for digital gangrene is well documented in the literature in both diabetic and PAD cohorts(6). Across the literature, rates of re-amputation at five years post-index surgery for diabetic foot complications range from 45-65% (6, 7). A recent study by Collins et al reported that, out of 146 Irish patients undergoing minor amputations, 43% (n=63) required further ipsilateral amputation, 21 (14.4%) of which were trans-tibial or trans-femoral(8). Chronic kidney disease, diabetes with or without poor gylcaemic control, peripheral neuropathy, peripheral arterial disease, ongoing tobacco smoking, obesity (BMI >30), concurrent sepsis at the time of index operation have all been identified as independent risk factors for amputation failure and the need for revision(9-11). While numerous studies have investigated patient-dependent factors predictive of amputation failure, there is a dearth of evidence examining the impact of surgical technique on this commonly performed procedure.
An exhaustive search of the literature surrounding surgical technique and outcomes after ray amputation yielded several papers on the benefits of various soft tissue flaps for covering wound defects but just one detailing a particular methods of bone transection. However, Moodley et al focused on the use of a Gigli saw, which is beyond the scope of this feasibility study(12). There have been no randomised controlled trials evaluating the impact of metatarsal transection method on outcomes after ray amputation, specifically whether a manual bone cutter or an electric/oscillating/pneumatic bone saw were used. We hypothesise that utilising a manual bone cutter is more subject to inter-user variability, as it depends on the physical strength of the operating surgeon; improperly applied forces are liable to fracture the remaining bone, leaving small comminuted fragments that may become necrotic and act as a nidus for further infection within the wound bed. Furthermore, using an oscillating microsaw has the advantage of providing a clean bony transection regardless of the physical strength of the operator, however it may cause more damage to the surrounding connective tissues and disturb microvascular periosteal supply, which could also lead to osteonecrosis. We propose a pilot randomised controlled trial to test the feasibility and to generate sufficient data to permit sample size calculation for a trial designed to evaluate the outcomes after ray amputation using either a bone cutter or a bone saw.
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed, Wound Complication, Critical Limb-Threatening Ischaemia
- Being tested
- Bone Saw, Bone Cutter
- Keywords
- diabetic foot infection, critical limb ischaemia, minor amputation, reulceration, wound complications
- Medical subject headings
- Diabetic Foot, Gangrene, Wound Infection, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone SawProcedure or surgery
The surgeon will use an oscillating microsaw to transect the metatarsal shaft
Bone CutterProcedure or surgery
The surgeon will use a manual bone cutter to transect the metatarsal shaft
| Study group | Role | What they receive |
|---|---|---|
| Bone Saw | Active comparator | In the "intervention" arm, the metatarsal bone will be transected using an oscillating microsaw. This is an accepted surgical method. Receives: Procedure: Bone Saw |
| Bone Cutter | Other | In the "control" arm, the metatarsal bone will be transected using a manual bone cutters. This is also an accepted surgical method Receives: Procedure: Bone Cutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power Calculation for Definitive RTC
collect sufficient data to enable an accurate power calculation for a future randomised controlled trial
Measured: Six months
Secondary outcomes (10)
Rate of Surgical Re-Intervention
To determine the effect of microsaw compared to bone cutters for toe amputation on rates of surgical reintervention at the index procedure site
Measured: Six months
Rate of Hospital Re-Admissions
To determine the effect of microsaw compared to bone cutters for toe amputation on rates of hospital re-admissions directly related to the index surgical procedure
Measured: Six months
Time to Wound Healing
To determine the effect of microsaw compared to bone cutters for toe amputation on time to healing of the index surgical wound
Measured: Six months
Rate of Index Ulcer Healing
To determine the effect of microsaw compared to bone cutters for toe amputation on healing of the index ulcer
Measured: Six months
Rate of Re-Infection
To determine the effect of microsaw compared to bone cutters for toe amputation on rates of re-infection at the index procedure site
Measured: six months
Rate of Ulcer Recurrence
To determine the effect of microsaw compared to bone cutters for toe amputation on ulcer recurrence or further ulceration
Measured: Six months
Rate of Recurrent Osteomyelitis
To determine the effect of microsaw compared to bone cutters for toe amputation on osteomyelitis recurrence adjacent to the index surgical site
Measured: Six months
Rate of Resection Margin Positive Culture
To determine the effect of microsaw compared to bone cutters for toe amputation on resection margin culture positivity
Measured: Six months
Patient-Reported Post-Operation Pain
To determine the effect of microsaw compared to bone cutters for toe amputation on patient-reported post-operative pain, as measured by the Verbal Rating Scale (VRS)
Measured: Six Months
Patient-Reported Quality of Life
To determine the effect of microsaw compared to bone cutters for toe amputation on patient-reported health-related quality of life at six weeks and six months, as measured by the EQ-5D-5L tool
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel randomised controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Power Foley, University College Hospital Galway
- Investigators
- Stewart R Walsh, FRCS, Principal investigator, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804565
- Sponsor's protocol ID
- 122/12
- Acronym
- MetaMet
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/j.atherosclerosis.2018.05.033. Epub 2018 May 22. No abstract available.
PubMed 29843915Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
PubMed 20609967Geiss LS, Li Y, Hora I, Albright A, Rolka D, Gregg EW. Resurgence of Diabetes-Related Nontraumatic Lower-Extremity Amputation in the Young and Middle-Aged Adult U.S. Population. Diabetes Care. 2019 Jan;42(1):50-54. doi: 10.2337/dc18-1380. Epub 2018 Nov 8.
PubMed 30409811Nolan JJ, O'Halloran D, McKenna TJ, Firth R, Redmond S. The cost of treating type 2 diabetes (CODEIRE). Ir Med J. 2006 Nov-Dec;99(10):307-10.
PubMed 17274175Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health Care Service and Outcomes Among an Estimated 6.7 Million Ambulatory Care Diabetic Foot Cases in the U.S. Diabetes Care. 2017 Jul;40(7):936-942. doi: 10.2337/dc16-2189. Epub 2017 May 11.
PubMed 28495903Armstrong DG, Lavery LA, Harkless LB, Van Houtum WH. Amputation and reamputation of the diabetic foot. J Am Podiatr Med Assoc. 1997 Jun;87(6):255-9. doi: 10.7547/87507315-87-6-255.
PubMed 9198345Rathnayake A, Saboo A, Malabu UH, Falhammar H. Lower extremity amputations and long-term outcomes in diabetic foot ulcers: A systematic review. World J Diabetes. 2020 Sep 15;11(9):391-399. doi: 10.4239/wjd.v11.i9.391.
PubMed 32994867Collins PM, Joyce DP, O'Beirn ES, Elkady R, Boyle E, Egan B, Tierney S. Re-amputation and survival following toe amputation: outcome data from a tertiary referral centre. Ir J Med Sci. 2022 Jun;191(3):1193-1199. doi: 10.1007/s11845-021-02682-4. Epub 2021 Jun 22.
PubMed 34156661Acar E, Kacira BK. Predictors of Lower Extremity Amputation and Reamputation Associated With the Diabetic Foot. J Foot Ankle Surg. 2017 Nov-Dec;56(6):1218-1222. doi: 10.1053/j.jfas.2017.06.004. Epub 2017 Jul 29.
PubMed 28765052Liu R, Petersen BJ, Rothenberg GM, Armstrong DG. Lower extremity reamputation in people with diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002325. doi: 10.1136/bmjdrc-2021-002325.
PubMed 34112651Norvell DC, Czerniecki JM. Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation. Eur J Vasc Endovasc Surg. 2020 Oct;60(4):614-621. doi: 10.1016/j.ejvs.2020.06.026. Epub 2020 Aug 13.
PubMed 32800475Moodley B, Grabowski G, Altschuler M, Williams M. Use of the Gigli saw for transmetatarsal amputations. J Foot Ankle Surg. 2005 Sep-Oct;44(5):415-8. doi: 10.1053/j.jfas.2005.07.013. No abstract available.
PubMed 16210164
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Metatarsal Method of Transection Using Bone Cutters or Bone Saw on Outcomes After Ray Amputation (MetaMet)
- ClinicalTrials.gov ID
- NCT05804565
- Acronym / sponsor ID
- MetaMet / 122/12
- Conditions
- Diabetic Foot, Gangrene; Limb, Wound Infection, Wound Healing Delayed, Wound Complication, Critical Limb-Threatening Ischaemia
- Keywords
- diabetic foot infection, critical limb ischaemia, minor amputation, reulceration, wound complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Toe amputation is a commonly performed operation for infection and/or ischaemia (tissue death due to lack of blood flow). However, a large number of patients having this surgery ultimately require further amputation due to poor wound healing, new infections and/or new ulcers. Research to date has focused on patient-related factors associated with poor wound healing (e.g. diabetes, lack of blood flow, poor kidney function). However, there is no research looking at the technical surgical aspects of the procedure, specifically how the toe bone is cut.
For this feasibility study, we will recruit forty patients whom a consultant vascular surgeon has decided requires amputation of one-to-two adjacent toes. The participants will be randomised by a computer model into one of the two metatarsal transection methods (bone cutters or bone saw) and the rest of the procedure will be carried out in the standard fashion. Patients and assessors will be blinded to which transection method is chosen.
Patients will undergo a post-operative foot x-ray to assess for bone fragments within 48 hours of surgery and another at six months to assess for bone healing. Patients will be asked to rate their pain in the post-operative period using the verbal rating score. Patients will be followed after discharge from hospital by their public health nurse, as is standard practice, with regular follow-up in the surgical outpatients to assess wound progress. Patients will be asked to rate their quality of life at six weeks and six months post-operatively. These assessments will be coordinated with their routine post-operative follow-up clinic appointments, so as not to inconvenience patients with supernumerary visits.
Detailed description
Toe amputation is a common minor vascular procedure and is increasingly performed in the context of irretrievable diabetic foot infection, with and without concurrent ischaemia. Approximately 422 million people worldwide have diabetes mellitus and peripheral arterial disease (PAD) affects approximately 200 million people(1). The intersection between diabetes, neuro-ischaemic foot ulceration and lower limb amputations is well established(2). Recently published data from the United States reported overall rates of lower limb amputations in diabetic patients rose between 2000 and 2015, in part due to a 62% increase in the rate of minor (foot and toe) amputations(3). It is estimated that 6% of Irish adults are diabetic; from this, we can extrapolate the burden of managing diabetic foot complications(4). Resource utilisation notwithstanding, the financial costs of managing diabetic foot complications are estimated to outstrip some cancers(5). As the prevalence of diabetes mellitus rises amongst an ageing Irish population, the importance of achieving durable functional outcomes after partial foot amputation is paramount.
Re-ulceration, re-infection, re-amputation and hospital re-admission after partial foot amputation for digital gangrene is well documented in the literature in both diabetic and PAD cohorts(6). Across the literature, rates of re-amputation at five years post-index surgery for diabetic foot complications range from 45-65% (6, 7). A recent study by Collins et al reported that, out of 146 Irish patients undergoing minor amputations, 43% (n=63) required further ipsilateral amputation, 21 (14.4%) of which were trans-tibial or trans-femoral(8). Chronic kidney disease, diabetes with or without poor gylcaemic control, peripheral neuropathy, peripheral arterial disease, ongoing tobacco smoking, obesity (BMI >30), concurrent sepsis at the time of index operation have all been identified as independent risk factors for amputation failure and the need for revision(9-11). While numerous studies have investigated patient-dependent factors predictive of amputation failure, there is a dearth of evidence examining the impact of surgical technique on this commonly performed procedure.
An exhaustive search of the literature surrounding surgical technique and outcomes after ray amputation yielded several papers on the benefits of various soft tissue flaps for covering wound defects but just one detailing a particular methods of bone transection. However, Moodley et al focused on the use of a Gigli saw, which is beyond the scope of this feasibility study(12). There have been no randomised controlled trials evaluating the impact of metatarsal transection method on outcomes after ray amputation, specifically whether a manual bone cutter or an electric/oscillating/pneumatic bone saw were used. We hypothesise that utilising a manual bone cutter is more subject to inter-user variability, as it depends on the physical strength of the operating surgeon; improperly applied forces are liable to fracture the remaining bone, leaving small comminuted fragments that may become necrotic and act as a nidus for further infection within the wound bed. Furthermore, using an oscillating microsaw has the advantage of providing a clean bony transection regardless of the physical strength of the operator, however it may cause more damage to the surrounding connective tissues and disturb microvascular periosteal supply, which could also lead to osteonecrosis. We propose a pilot randomised controlled trial to test the feasibility and to generate sufficient data to permit sample size calculation for a trial designed to evaluate the outcomes after ray amputation using either a bone cutter or a bone saw.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 parallel randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bone Saw | Active comparator | Procedure: Bone SawIn the "intervention" arm, the metatarsal bone will be transected using an oscillating microsaw. This is an accepted surgical method. |
| Bone Cutter | Other | Procedure: Bone CutterIn the "control" arm, the metatarsal bone will be transected using a manual bone cutters. This is also an accepted surgical method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients, aged 18 and over, undergoing transmetatarsal amputation of one-to-two adjacent toes
Key exclusion criteria (4 listed)
- Significant peripheral arterial disease, as defined by ABPI <0.4 or digital pressures of <50mmHg, not undergoing concurrent revascularisation;
- Patients undergoing amputation of three of more adjacent toes
- Patients unfit for surgery;
- Patients unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone SawThe surgeon will use an oscillating microsaw to transect the metatarsal shaft | Procedure or surgery | Bone Saw |
| Bone CutterThe surgeon will use a manual bone cutter to transect the metatarsal shaft | Procedure or surgery | Bone Cutter |
Primary outcome
Power Calculation for Definitive RTC
Time frame: Six months
collect sufficient data to enable an accurate power calculation for a future randomised controlled trial
10 secondary outcomes
Rate of Surgical Re-Intervention
Time frame: Six months
Rate of Hospital Re-Admissions
Time frame: Six months
Time to Wound Healing
Time frame: Six months
Rate of Index Ulcer Healing
Time frame: Six months
Rate of Re-Infection
Time frame: six months
Rate of Ulcer Recurrence
Time frame: Six months
Rate of Recurrent Osteomyelitis
Time frame: Six months
Rate of Resection Margin Positive Culture
Time frame: Six months
Patient-Reported Post-Operation Pain
Time frame: Six Months
Patient-Reported Quality of Life
Time frame: Six Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 29843915Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/j.atherosclerosis.2018.05.033. Epub 2018 May 22. No abstract available.
- Background: PubMed 20609967Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
- Background: PubMed 30409811Geiss LS, Li Y, Hora I, Albright A, Rolka D, Gregg EW. Resurgence of Diabetes-Related Nontraumatic Lower-Extremity Amputation in the Young and Middle-Aged Adult U.S. Population. Diabetes Care. 2019 Jan;42(1):50-54. doi: 10.2337/dc18-1380. Epub 2018 Nov 8.
- Background: PubMed 17274175Nolan JJ, O'Halloran D, McKenna TJ, Firth R, Redmond S. The cost of treating type 2 diabetes (CODEIRE). Ir Med J. 2006 Nov-Dec;99(10):307-10.
- Background: PubMed 28495903Skrepnek GH, Mills JL Sr, Lavery LA, Armstrong DG. Health Care Service and Outcomes Among an Estimated 6.7 Million Ambulatory Care Diabetic Foot Cases in the U.S. Diabetes Care. 2017 Jul;40(7):936-942. doi: 10.2337/dc16-2189. Epub 2017 May 11.
- Background: PubMed 9198345Armstrong DG, Lavery LA, Harkless LB, Van Houtum WH. Amputation and reamputation of the diabetic foot. J Am Podiatr Med Assoc. 1997 Jun;87(6):255-9. doi: 10.7547/87507315-87-6-255.
- Background: PubMed 32994867Rathnayake A, Saboo A, Malabu UH, Falhammar H. Lower extremity amputations and long-term outcomes in diabetic foot ulcers: A systematic review. World J Diabetes. 2020 Sep 15;11(9):391-399. doi: 10.4239/wjd.v11.i9.391.
- Background: PubMed 34156661Collins PM, Joyce DP, O'Beirn ES, Elkady R, Boyle E, Egan B, Tierney S. Re-amputation and survival following toe amputation: outcome data from a tertiary referral centre. Ir J Med Sci. 2022 Jun;191(3):1193-1199. doi: 10.1007/s11845-021-02682-4. Epub 2021 Jun 22.
- Background: PubMed 28765052Acar E, Kacira BK. Predictors of Lower Extremity Amputation and Reamputation Associated With the Diabetic Foot. J Foot Ankle Surg. 2017 Nov-Dec;56(6):1218-1222. doi: 10.1053/j.jfas.2017.06.004. Epub 2017 Jul 29.
- Background: PubMed 34112651Liu R, Petersen BJ, Rothenberg GM, Armstrong DG. Lower extremity reamputation in people with diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2021 Jun;9(1):e002325. doi: 10.1136/bmjdrc-2021-002325.
- Background: PubMed 32800475Norvell DC, Czerniecki JM. Risks and Risk Factors for Ipsilateral Re-Amputation in the First Year Following First Major Unilateral Dysvascular Amputation. Eur J Vasc Endovasc Surg. 2020 Oct;60(4):614-621. doi: 10.1016/j.ejvs.2020.06.026. Epub 2020 Aug 13.
- Background: PubMed 16210164Moodley B, Grabowski G, Altschuler M, Williams M. Use of the Gigli saw for transmetatarsal amputations. J Foot Ankle Surg. 2005 Sep-Oct;44(5):415-8. doi: 10.1053/j.jfas.2005.07.013. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart R Walsh, FRCS principal investigator
University College Hospital Galway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Saw and Bone Cutter in people with Diabetic Foot and Gangrene; Limb, run by University College Hospital Galway at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Power Foley, MRCS (871312557 ext. 00353, foleymp@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Power Calculation for Definitive RTC (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05804565, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.