Muscle LossMTEC-VMLNCT04051242
Enhanced Bioscaffold for Volumetric Muscle Loss
A study testing XenMatrix™ AB Surgical Graft in people with Muscle Loss, run by J. Peter Rubin, MD at 1 site in United States.
Trial summary
This is a prospective, single center study conducted at the University of Pittsburgh designed to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after soft tissue trauma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Loss
- What is being tested?
- XenMatrix™ AB Surgical Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years of age and able to provide informed consent
- Civilian, and current or former military personnel are eligible to participate
- Have suffered injury resulting in a structural deficit of a minimum of 20% of the muscle group mass and a functional deficit of a minimum of 25% when compared to a contralateral limb present; or if bilateral injury is present to extremities, the potential surgical extremity is to be compared against normal expected values of a sample population of similar age and gender and evidence of remaining tendon and musculotendinous units that could be surgically repaired with sutures.
- Injuries may encompass a single muscle belly or compartment, whether an area is expected to be repaired by sutures will be determined from imaging studies and physical examination. Muscle groups which originate or attach to the long bones of the extremity, and which directly affect strength and function (i.e., Pectoralis Major, Coracobrachialis, Subscapularis, Teres Major/Minor, Latissimus Dorsi, Supraspinatus, Infraspinatus, Gluteus group, Tensor fasciae latae, Piriformis, and quadratus femoris) will also be included in this clinical trial.
- Have suffered traumatic injury within the last 18 months to the upper and/or lower extremity; Target of 18 months or less but subject's may be enrolled with injury outside this range if the principal investigator determines that there is viable muscle in the injured compartment determined by clinical exam and imaging studies.
- Eligible for study procedures 3 months post injury with stability determined by the Principal Investigator and/ or Physician Co-Investigator
- Willing and able to comply with follow up examinations, radiographic studies, physical therapy, muscle biopsy and laboratory tests.
Who cannot join
- Inability to provide informed consent
- Poor nutrition (demonstrated by clinically significant abnormal lab results for serum albumin and pre-albumin values, per the investigator's discretion)
- Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes
- Active and unstable disease state or infection anywhere in the body per Physician's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, Liver function and chemistry panel values)
- Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
- Pregnancy (demonstrated by a positive result of a urine pregnancy test)• Diagnosis of cancer within last 12 months and /or actively receiving chemotherapy or radiation treatment
Show all 11Show fewer
- Subjects with an Axis I diagnosis DSM-IV (e.g., Schizophrenia, Bipolar Disorder). Subjects who are found to be stable on medication and receive psychiatric clearance could be eligible for study participation per the Physician's discretion
- .• Subjects with complete muscle/tendon gaps greater than 5 cm that are obvious on imaging studies and are unlikely to be reasonably repaired with sutures and reinforcement, and will be excluded. The investigators recognize that these findings may not be clear on imaging studies, and that the clinical judgment of the surgeon shall be applied in each case.
- Subjects with a known hypersensitivity to porcine serum products
- Allergies to the antibiotics, Rifampin, minocycline, tetracycline currently associated with the XenMatrix AB Surgical Graft
- Any condition or situation as it relates to the subject's health or safety, that would render concern to the investigators, and therefore preclude subject enrollment in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Aesthetic Plastic Surgery Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: XENMATRIX™ AB Surgical Graft for the Repair of Severe Musculotendinous Tissue Damaged by Soft Tissue Trauma
This is a prospective, single center study conducted at the University of Pittsburgh designed to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after soft tissue trauma.
Read the detailed description
Previously, a human subject clinical trial (NCT01292876, PRO10010500) to evaluate a regenerative medicine approach using ECM for VML treatment was conducted. ECM scaffolds were implanted and combined with aggressive and early physical therapy in 13 subjects, then followed for 24-28 weeks after implantation. Histomorphological assessments collected from core needle biopsies identified formation of new, vascularized, innervated islands of skeletal muscle within the implantation site. Subjects demonstrated increased force production in physical therapy evaluations and improved functional task performance when compared with pre-operative performance. By 6 months after ECM implantation, subjects had a 37.3% improvement in strength and 27.1% improvement in range-of-motion tasks. Additionally, changes in nerve conduction study (NCS) and electromyography (EMG) before and after ECM implantation were measured. 63% of study participants experienced improvements in NCS or EMG within the scaffold remodeling site, indicating clinical improvement in muscle strength. The promising functional and regenerative results from this early study encourages evidence of ECM bioscaffolding as a viable treatment to VML.
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The graft has an antibiotic coating, specifically, Rifampin and Minocycline. This coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not yet been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated and will need further investigation. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma. 10 subjects will be enrolled for participation in the study. Prior to Graft implantation, subjects will receive a pre-operative course of physical therapy for a maximum time period of 16 weeks. A physical therapist will confirm that functional plateau is reached prior to implantation of the Graft. Following Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
- Conditions
- Muscle Loss
- Being tested
- XenMatrix™ AB Surgical Graft
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenMatrix™ AB Surgical GraftDevice
Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
| Study group | Role | What they receive |
|---|---|---|
| XenMatrix AB Surgical Graft | Experimental | This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma Receives: Device: XenMatrix™ AB Surgical Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extremity Function; as Reported by Participant During a Physical Therapy Evaluation, Pre and Post Study Surgical Intervention, Using the Foot and Ankle Ability Measure (FAAM), Activities of Daily Living (ADL) Subscale Score.
The Foot and Ankle Ability Measure (FAAM) activities of daily living subscale asks respondents to report on whether their activity was limited in the last week due to difficulties with their foot/ankle. The self-assessment uses a 5-point Likert scale from, and has a 6th option, not applicable, if difficulties are not specific to the foot/ankle. Answer choices include No difficulty, slight difficulty, moderate difficulty, extreme difficulty or unable to do. There are two subscales, activities of daily living and sports. For activities of daily living maximum score is 84 and lowest possible score is 0. (For the sports scale the maximum is 28 and the lowest possible score is zero. Higher scores indicate less difficulty with performing the activities. The FAAM sub scores are not totaled together but reported separately). For this subject, due to his injury, the investigators are reporting the Activities of Daily Living Subscale.
Measured: Baseline, 6 month follow up
Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
Assessment of patient extremity mechanical strength in right and left knee, post implantation of XENMATRIX AB™ Surgical Graft; after skeletal muscle injury as determined by physical therapy assessment using knee flexion force, as measured by dynamometry using newtons. Knee flexion force was measured three times, at each timepoint, so both the mean and lowest and highest score are reported below.
Measured: Baseline, 6 month follow up
Secondary outcomes (1)
Number of Participants With Infection With the Use of XENMATRIX AB™ Surgical Graft
Number of Participants with Infection with the Use of XENMATRIX AB™ Surgical Graft. Two participants received the XENMATRIX AB™ Surgical Graft, during their study surgical intervention.
Measured: 9-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start10 Feb 2020
- Primary completion24 Jan 2024
- Study completion24 Jan 2024
Why it stopped: Did not complete planned enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- J. Peter Rubin, MD
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, J. Peter Rubin, MD, University of Pittsburgh
- Investigators
- J. Peter Rubin, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051242
- Sponsor's protocol ID
- STUDY19040344
- Acronym
- MTEC-VML
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2019
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Dziki J, Badylak S, Yabroudi M, Sicari B, Ambrosio F, Stearns K, Turner N, Wyse A, Boninger ML, Brown EHP, Rubin JP. An acellular biologic scaffold treatment for volumetric muscle loss: results of a 13-patient cohort study. NPJ Regen Med. 2016 Jul 21;1:16008. doi: 10.1038/npjregenmed.2016.8. eCollection 2016.
PubMed 29302336Han N, Yabroudi MA, Stearns-Reider K, Helkowski W, Sicari BM, Rubin JP, Badylak SF, Boninger ML, Ambrosio F. Electrodiagnostic Evaluation of Individuals Implanted With Extracellular Matrix for the Treatment of Volumetric Muscle Injury: Case Series. Phys Ther. 2016 Apr;96(4):540-9. doi: 10.2522/ptj.20150133. Epub 2015 Nov 12.
PubMed 26564252
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XENMATRIX™ AB Surgical Graft for the Repair of Severe Musculotendinous Tissue Damaged by Soft Tissue Trauma
- ClinicalTrials.gov ID
- NCT04051242
- Acronym / sponsor ID
- MTEC-VML / STUDY19040344
- Conditions
- Muscle Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Did not complete planned enrollment.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- J. Peter Rubin, MDUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single center study conducted at the University of Pittsburgh designed to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after soft tissue trauma.
Detailed description
Previously, a human subject clinical trial (NCT01292876, PRO10010500) to evaluate a regenerative medicine approach using ECM for VML treatment was conducted. ECM scaffolds were implanted and combined with aggressive and early physical therapy in 13 subjects, then followed for 24-28 weeks after implantation. Histomorphological assessments collected from core needle biopsies identified formation of new, vascularized, innervated islands of skeletal muscle within the implantation site. Subjects demonstrated increased force production in physical therapy evaluations and improved functional task performance when compared with pre-operative performance. By 6 months after ECM implantation, subjects had a 37.3% improvement in strength and 27.1% improvement in range-of-motion tasks. Additionally, changes in nerve conduction study (NCS) and electromyography (EMG) before and after ECM implantation were measured. 63% of study participants experienced improvements in NCS or EMG within the scaffold remodeling site, indicating clinical improvement in muscle strength. The promising functional and regenerative results from this early study encourages evidence of ECM bioscaffolding as a viable treatment to VML.
This study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The graft has an antibiotic coating, specifically, Rifampin and Minocycline. This coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not yet been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated and will need further investigation. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma. 10 subjects will be enrolled for participation in the study. Prior to Graft implantation, subjects will receive a pre-operative course of physical therapy for a maximum time period of 16 weeks. A physical therapist will confirm that functional plateau is reached prior to implantation of the Graft. Following Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XenMatrix AB Surgical Graft | Experimental | Device: XenMatrix™ AB Surgical GraftThis study proposes to use XenMatrix™ AB Surgical Graft which has 510(k) approval [#K162193] intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue. This trial proposes to test the applicability and utility of XenMatrix™ AB Surgical Graft in the restoration of function in the setting of volumetric muscle loss after trauma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 to 70 years of age and able to provide informed consent
- Civilian, and current or former military personnel are eligible to participate
- Have suffered injury resulting in a structural deficit of a minimum of 20% of the muscle group mass and a functional deficit of a minimum of 25% when compared to a contralateral limb present; or if bilateral injury is present to extremities, the potential surgical extremity is to be compared against normal expected values of a sample population of similar age and gender and evidence of remaining tendon and musculotendinous units that could be surgically repaired with sutures.
- Injuries may encompass a single muscle belly or compartment, whether an area is expected to be repaired by sutures will be determined from imaging studies and physical examination. Muscle groups which originate or attach to the long bones of the extremity, and which directly affect strength and function (i.e., Pectoralis Major, Coracobrachialis, Subscapularis, Teres Major/Minor, Latissimus Dorsi, Supraspinatus, Infraspinatus, Gluteus group, Tensor fasciae latae, Piriformis, and quadratus femoris) will also be included in this clinical trial.
- Have suffered traumatic injury within the last 18 months to the upper and/or lower extremity; Target of 18 months or less but subject's may be enrolled with injury outside this range if the principal investigator determines that there is viable muscle in the injured compartment determined by clinical exam and imaging studies.
Key exclusion criteria (11 listed)
- Inability to provide informed consent
- Poor nutrition (demonstrated by clinically significant abnormal lab results for serum albumin and pre-albumin values, per the investigator's discretion)
- Chronic disease such as congestive heart failure, liver disease, renal disease, or diabetes
- Active and unstable disease state or infection anywhere in the body per Physician's evaluation and determination (demonstrated by stated or medical record history and abnormal lab range for CBC with Differential and Platelet, Liver function and chemistry panel values)
- Known coagulopathy (demonstrated by stated or medical record history of diagnosis)
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 |
|---|---|---|
| XenMatrix™ AB Surgical GraftGraft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4). | Device | XenMatrix AB Surgical Graft |
Primary outcome
Extremity Function; as Reported by Participant During a Physical Therapy Evaluation, Pre and Post Study Surgical Intervention, Using the Foot and Ankle Ability Measure (FAAM), Activities of Daily Living (ADL) Subscale Score.
Time frame: Baseline, 6 month follow up
The Foot and Ankle Ability Measure (FAAM) activities of daily living subscale asks respondents to report on whether their activity was limited in the last week due to difficulties with their foot/ankle. The self-assessment uses a 5-point Likert scale from, and has a 6th option, not applicable, if difficulties are not specific to the foot/ankle. Answer choices include No difficulty, slight difficulty, moderate difficulty, extreme difficulty or unable to do. There are two subscales, activities of daily living and sports. For activities of daily living maximum score is 84 and lowest possible score is 0. (For the sports scale the maximum is 28 and the lowest possible score is zero. Higher scores indicate less difficulty with performing the activities. The FAAM sub scores are not totaled together but reported separately). For this subject, due to his injury, the investigators are reporting the Activities of Daily Living Subscale.
Extremity Strength in Right and Left Knee (as Measured by Dynamometry Using Newtons, in a Knee Flexion Force Exercise), Pre and Post Surgical Intervention at Baseline and 6 Month Follow up.
Time frame: Baseline, 6 month follow up
Assessment of patient extremity mechanical strength in right and left knee, post implantation of XENMATRIX AB™ Surgical Graft; after skeletal muscle injury as determined by physical therapy assessment using knee flexion force, as measured by dynamometry using newtons. Knee flexion force was measured three times, at each timepoint, so both the mean and lowest and highest score are reported below.
1 secondary outcome
Number of Participants With Infection With the Use of XENMATRIX AB™ Surgical Graft
Time frame: 9-11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29302336Dziki J, Badylak S, Yabroudi M, Sicari B, Ambrosio F, Stearns K, Turner N, Wyse A, Boninger ML, Brown EHP, Rubin JP. An acellular biologic scaffold treatment for volumetric muscle loss: results of a 13-patient cohort study. NPJ Regen Med. 2016 Jul 21;1:16008. doi: 10.1038/npjregenmed.2016.8. eCollection 2016.
- Background: PubMed 26564252Han N, Yabroudi MA, Stearns-Reider K, Helkowski W, Sicari BM, Rubin JP, Badylak SF, Boninger ML, Ambrosio F. Electrodiagnostic Evaluation of Individuals Implanted With Extracellular Matrix for the Treatment of Volumetric Muscle Injury: Case Series. Phys Ther. 2016 Apr;96(4):540-9. doi: 10.2522/ptj.20150133. Epub 2015 Nov 12.
- Individual participant dataSharing planned: No
Related trials for Muscle Loss
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
RecruitingObservational study
Sarcopenia and Training Outcomes in Post-cardiac Surgery Patients
Sarcopenia, Cardiac Surgery
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.
J. Peter Rubin, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XenMatrix™ AB Surgical Graft in people with Muscle Loss, run by J. Peter Rubin, MD at 1 site in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 Apr 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extremity Function; as Reported by Participant During a Physical Therapy Evaluation, Pre and Post Study Surgical Intervention, Using the Foot and Ankle Ability Measure (FAAM), Activities of Daily Living (ADL) Subscale Score. (time frame: Baseline, 6 month follow up). The study lists 2 primary outcomes in all. 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 NCT04051242, which also lists 2 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 25 Apr 2025.