Wound HealPhase 1CiNPWTNCT06493539
CiNPWT Lower Extremity Amputations (Closed Incision Neagtive Pressure Wound Therapy)
A Phase 1 study testing CINPWT in people with Wound Heal and Wound Dehiscence, run by University of Southern California.
Trial summary
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Wound Dehiscence
- What is being tested?
- CINPWT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2024to 30 Jun 2025
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individual presents with any defined contraindications to NPWT (e.g., allergy).
- Individual presents with residual acute osteomyelitis (after amputation).
- Individual with collagen vascular disease or malignant disease in the wound
- Individual has uncontrolled hyperglycemia (glycosylated hemoglobin [HbA1c]>12%).
- Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator
- Individual has a history of local radiation therapy that could impact the edema of the amputated limb.
Show all 12Show fewer
- Individual has pre-existing conditions contributing to residual limb edema (i.e., nephropathy, congestive heart failure, primary lymphedema, etc.).
- Withdrawal of individuals:
- Voluntary withdrawal
- Death
- Lost to follow-up
- Termination of compression therapy (control or intervention group)
About this study
Official title: A Novel Application of Closed Incision Negative Pressure Wound Therapy for the Post-Surgical Management of Lower Extremity Amputations: A Randomized Clinical Pilot Study
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA.
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
Read the detailed description
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy (CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation (LEA) compared with standard of care compression wrapping and wound care post-LEA.
Specific objectives:
- Collect demographics and relevant data (e.g., risk factors and comorbidities) to compare intervention and control groups.
- Measure post-surgical outcomes and compare both groups.
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
DEVICE INFORMATION
The V.A.C. Ulta™ Therapy System (3M, USA) is a non-invasive wound closure system that uses controlled, localized negative pressure to promote healing in chronic and acute wounds. The subatmospheric (ie. negative) pressure system uses latex-free and sterile polyurethane or polyvinyl alcohol foam dressings that are individualized at the bedside to the appropriate size for every patient, and then covered with an adhesive drape to create an airtight seal. A SensaT.R.A.C.™ Pad directly contacts the foam dressing, and accurately senses, monitors, and maintains the target pressure at the wound site to provide controlled negative pressure. Tubing attached to the SensaT.R.A.C.™ Pad connects to a fluid collection canister contained in a programmable, portable, computer-controlled vacuum pump creating negative pressure at the wound surface interface.
Amputation (and revision/re-amputation) is a resection of a segment of a limb through a bone or through a joint.
Major amputation: Any resection proximal to the ankle.
Major amputation levels:
TT = transtibial amputation: amputation through the tibia and fibula (frequently referred to as "below knee amputation").
KD = knee disarticulation: amputation through the knee (frequently referred to as "through knee amputation").
TF = transfemoral amputation: amputation through the femur (frequently referred to as "above knee amputation").
Minor amputation: Any resection distal to the ankle.
Minor amputation levels:
TMA= transmetartarsal amputation.
The level will be determined using the electronic medical record of the patients and by the health care providers observations.
Wound dehiscence (partial or total) is a surgery complication where the incision reopens. Clinically reported by the health care providers. This will be also evaluated with digital photographs.
Infection at the surgical site and/or cellulitis of the residual limb are pathological states caused by invasion and multiplication of microorganisms in host tissues accompanied by tissue destruction and/or a host inflammatory response. This is usually based on soft tissue infection clinical criteria from Infectious Disease Society of America (IDSA) and will be reported by the health care provider.
Closed wound, defined as complete epithelialization at the surgical site, will be based on the health provider's clinical decision combined with medical record documentation. Determination is based on data from wound assessments and photographs performed by the treating clinician and documented in the Tissue Analytics wound imaging software. Photographs will be taken during patient visits (no more than 3x/wk) and if present, wound size, and tissue color percentages will be calculated by Tissue Analytics software. Any wound depth present will be measured manually by the treating therapist and entered into the Tissue Analytics system. Additional wound assessment characteristics that will be documented include periwound color and condition, drainage type or amount, and tissue type assessment. Agreement between clinician's documentation of closure and photographic measurements will be used to ascertain time to closure.
The tolerability/acceptability of CiNPWT will be measured:
- Pain which is a physical suffering or discomfort caused by CiNPWT is usually reported by the patient using the visual analogue scale at each visit.
- Anxiety about the treatment using Hamilton Anxiety Rating Scale (HAM-A)
- Quality of life using the Short Form-36 Questionaire
Baseline characteristics, risk factors and comorbidities will be extracted from the electronic medical record and validated with physical examination. Investigations can be done as necessary to complete missing data such as presence/absence of neuropathy, vascular status, etc., using best practice at the initial evaluation. As an example, blood samples will be obtained at the first evaluation to assess Hemoglobin A1c. If a patient is deemed at nutrition risk based on a nutrition screen done by nursing (Malnutrition Screening Tool), a dietitian will be consulted, and dietary supplementation will be initiated as needed.
All unscheduled or emergency visits will be listed.
At each encounter, the time to complete the treatment including dressings and compression (intervention and control) will be recorded by the clinician in the Electronic Medical Record.
- Conditions
- Wound Heal, Wound Dehiscence
- Being tested
- Standard of Care group, CINPWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care groupProcedure or surgery
The control group will receive standard of care wound treatment
CINPWTDevice
Subject will receive CINPWT until discharged
| Study group | Role | What they receive |
|---|---|---|
| Control group: Standard of Care | Active comparator | Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily. Receives: Procedure: Standard of Care group |
| CiNPWT treatment group | Experimental | Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as ~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days.
A patient may always be removed from treatment intervention whenever they wish. Receives: Device: CINPWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reduction of edema as assessed using Girth measurements and Grading system.
Measurement of edema reduction using the +1 to +4 grading system as well as girth measurements of lower extremity of using measuring tape.
Measured: Up to 8 weeks
Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback.
Determine the overall tolerability, acceptability, and convenience of the intervention using Patient surveys and patient provided feedback.
Measured: Up to 8 weeks
Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch.
CiNPWT effect on ambulation by measuring time to ambulation, time to weight-bearing as measured by a stopwatch.
Measured: Up to 8 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
CiNPWT on number of needed physical therapy visits, adverse events, surgical site infection, re-amputation/revision rate, dehiscence, dressing failure, unscheduled/emergency encounters, hospital-acquired pressure injuries.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Why it stopped: No patients recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as \~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days. A patient may always be removed from treatment intervention whenever they wish. Control Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, David Armstrong, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493539
- Sponsor's protocol ID
- APP-22-00260 USC
- Acronym
- CiNPWT
- Status last verified
- Jan 2026
- First submitted
- 5 May 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fortington LV, Geertzen JH, van Netten JJ, Postema K, Rommers GM, Dijkstra PU. Short and long term mortality rates after a lower limb amputation. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):124-31. doi: 10.1016/j.ejvs.2013.03.024. Epub 2013 Apr 28.
PubMed 23628328Low EE, Inkellis E, Morshed S. Complications and revision amputation following trauma-related lower limb loss. Injury. 2017 Feb;48(2):364-370. doi: 10.1016/j.injury.2016.11.019. Epub 2016 Nov 18.
PubMed 27890336Morisaki K, Yamaoka T, Iwasa K. Risk factors for wound complications and 30-day mortality after major lower limb amputations in patients with peripheral arterial disease. Vascular. 2018 Feb;26(1):12-17. doi: 10.1177/1708538117714197. Epub 2017 Jun 6.
PubMed 28587576Goldberg T. Postoperative management of lower extremity amputations. Phys Med Rehabil Clin N Am. 2006 Feb;17(1):173-80, vii. doi: 10.1016/j.pmr.2005.10.009.
PubMed 16517350Ahuja V, Thapa D, Ghai B. Strategies for prevention of lower limb post-amputation pain: A clinical narrative review. J Anaesthesiol Clin Pharmacol. 2018 Oct-Dec;34(4):439-449. doi: 10.4103/joacp.JOACP_126_17.
PubMed 30774224Nawijn SE, van der Linde H, Emmelot CH, Hofstad CJ. Stump management after trans-tibial amputation: a systematic review. Prosthet Orthot Int. 2005 Apr;29(1):13-26. doi: 10.1080/17461550500066832.
PubMed 16180374Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.
PubMed 26994715Scalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, Gesuita R, Di Benedetto G. Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2016 Dec;13(6):1260-1281. doi: 10.1111/iwj.12492. Epub 2015 Oct 1.
PubMed 26424609Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.
PubMed 28885895Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
PubMed 16291063Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189.
PubMed 22068373Zwanenburg PR, Timmermans FW, Timmer AS, Middelkoop E, Tol BT, Lapid O, Obdeijn MC, Gans SL, Boermeester MA. A systematic review evaluating the influence of incisional Negative Pressure Wound Therapy on scarring. Wound Repair Regen. 2021 Jan;29(1):8-19. doi: 10.1111/wrr.12858. Epub 2020 Aug 21.
PubMed 32789902West J, Wetherhold J, Schulz S, Valerio I. A Novel Use of Next-Generation Closed Incision Negative Pressure Wound Therapy After Major Limb Amputation and Amputation Revision. Cureus. 2020 Sep 11;12(9):e10393. doi: 10.7759/cureus.10393.
PubMed 33062513Kilpadi DV, Olivie M. Evaluation of closed incision negative pressure therapy systems on the closure of incisional space model. J Wound Care. 2019 Dec 2;28(12):850-860. doi: 10.12968/jowc.2019.28.12.850.
PubMed 31825775Singh D, Livingstone JP, Lautze J, Murray PC. Measuring In-Vivo Foot Perfusion Distal to a Near-Circumferential Negative Pressure Wound Therapy Dressing via Thermal Imaging. Cureus. 2021 Sep 4;13(9):e17720. doi: 10.7759/cureus.17720. eCollection 2021 Sep.
PubMed 34650894
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Application of Closed Incision Negative Pressure Wound Therapy for the Post-Surgical Management of Lower Extremity Amputations: A Randomized Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT06493539
- Acronym / sponsor ID
- CiNPWT / APP-22-00260 USC
- Conditions
- Wound Heal, Wound Dehiscence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Jul 2024 (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.
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy(CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation(LEA) compared with standard of care compression wrapping and wound care post-LEA.
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
Detailed description
The objective of this study is to evaluate prospectively the effect of a novel application of Closed Incision Negative Pressure Wound Therapy (CiNPWT), as delivered by the V.A.C. Ulta™ Therapy System (3M, USA) in individuals who have undergone a Lower Extremity Amputation (LEA) compared with standard of care compression wrapping and wound care post-LEA.
Specific objectives:
- Collect demographics and relevant data (e.g., risk factors and comorbidities) to compare intervention and control groups.
- Measure post-surgical outcomes and compare both groups.
STUDY DESIGN
This a pilot-controlled exploratory trial including approximately 6-10 individuals who have undergone LEA (trans-metatarsal or higher) randomized between intervention (novel application of CiNPWT) and a control group (standard care).
DEVICE INFORMATION
The V.A.C. Ulta™ Therapy System (3M, USA) is a non-invasive wound closure system that uses controlled, localized negative pressure to promote healing in chronic and acute wounds. The subatmospheric (ie. negative) pressure system uses latex-free and sterile polyurethane or polyvinyl alcohol foam dressings that are individualized at the bedside to the appropriate size for every patient, and then covered with an adhesive drape to create an airtight seal. A SensaT.R.A.C.™ Pad directly contacts the foam dressing, and accurately senses, monitors, and maintains the target pressure at the wound site to provide controlled negative pressure. Tubing attached to the SensaT.R.A.C.™ Pad connects to a fluid collection canister contained in a programmable, portable, computer-controlled vacuum pump creating negative pressure at the wound surface interface.
Amputation (and revision/re-amputation) is a resection of a segment of a limb through a bone or through a joint.
Major amputation: Any resection proximal to the ankle.
Major amputation levels:
TT = transtibial amputation: amputation through the tibia and fibula (frequently referred to as "below knee amputation").
KD = knee disarticulation: amputation through the knee (frequently referred to as "through knee amputation").
TF = transfemoral amputation: amputation through the femur (frequently referred to as "above knee amputation").
Minor amputation: Any resection distal to the ankle.
Minor amputation levels:
TMA= transmetartarsal amputation.
The level will be determined using the electronic medical record of the patients and by the health care providers observations.
Wound dehiscence (partial or total) is a surgery complication where the incision reopens. Clinically reported by the health care providers. This will be also evaluated with digital photographs.
Infection at the surgical site and/or cellulitis of the residual limb are pathological states caused by invasion and multiplication of microorganisms in host tissues accompanied by tissue destruction and/or a host inflammatory response. This is usually based on soft tissue infection clinical criteria from Infectious Disease Society of America (IDSA) and will be reported by the health care provider.
Closed wound, defined as complete epithelialization at the surgical site, will be based on the health provider's clinical decision combined with medical record documentation. Determination is based on data from wound assessments and photographs performed by the treating clinician and documented in the Tissue Analytics wound imaging software. Photographs will be taken during patient visits (no more than 3x/wk) and if present, wound size, and tissue color percentages will be calculated by Tissue Analytics software. Any wound depth present will be measured manually by the treating therapist and entered into the Tissue Analytics system. Additional wound assessment characteristics that will be documented include periwound color and condition, drainage type or amount, and tissue type assessment. Agreement between clinician's documentation of closure and photographic measurements will be used to ascertain time to closure.
The tolerability/acceptability of CiNPWT will be measured:
- Pain which is a physical suffering or discomfort caused by CiNPWT is usually reported by the patient using the visual analogue scale at each visit.
- Anxiety about the treatment using Hamilton Anxiety Rating Scale (HAM-A)
- Quality of life using the Short Form-36 Questionaire
Baseline characteristics, risk factors and comorbidities will be extracted from the electronic medical record and validated with physical examination. Investigations can be done as necessary to complete missing data such as presence/absence of neuropathy, vascular status, etc., using best practice at the initial evaluation. As an example, blood samples will be obtained at the first evaluation to assess Hemoglobin A1c. If a patient is deemed at nutrition risk based on a nutrition screen done by nursing (Malnutrition Screening Tool), a dietitian will be consulted, and dietary supplementation will be initiated as needed.
All unscheduled or emergency visits will be listed.
At each encounter, the time to complete the treatment including dressings and compression (intervention and control) will be recorded by the clinician in the Electronic Medical Record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Following amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as ~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days. A patient may always be removed from treatment intervention whenever they wish. Control Following amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily.
| Arm | Type | Receives |
|---|---|---|
| Control group: Standard of Care | Active comparator | Procedure: Standard of Care groupFollowing amputation, at POD 1, application of standard care (short stretch compression bandages and standard post-operative wound care) daily. |
| CiNPWT treatment group | Experimental | Device: CINPWTFollowing amputation, at POD 1, CiNPWT will be applied in an "envelope-like" fashion, incorporating the incison line as well as ~10 cm of intact proximal residual limb tissue. The underlying skin will be protected with a contact layer and the negative pressure foam is applied for maximal surface area coverage. Negative pressure parameters are set to dynamic pressure control therapy (DPC) from -25 mmHg to -125 mmHg with a 2 minute on/2 minute off cycle and the dressing is left in place for three to five days. A patient may always be removed from treatment intervention whenever they wish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Individual presents with any defined contraindications to NPWT (e.g., allergy).
- Individual presents with residual acute osteomyelitis (after amputation).
- Individual with collagen vascular disease or malignant disease in the wound
- Individual has uncontrolled hyperglycemia (glycosylated hemoglobin [HbA1c]>12%).
- Individual is currently taking corticosteroids, immunosuppressive drugs, or chemotherapy and is not on stable course of therapy as determined by principal investigator
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 |
|---|---|---|
| Standard of Care groupThe control group will receive standard of care wound treatment | Procedure or surgery | Control group: Standard of Care |
| CINPWTSubject will receive CINPWT until discharged | Device | CiNPWT treatment group |
Primary outcome
Number of participants with reduction of edema as assessed using Girth measurements and Grading system.
Time frame: Up to 8 weeks
Measurement of edema reduction using the +1 to +4 grading system as well as girth measurements of lower extremity of using measuring tape.
Number of participants with Greater acceptability, tolerability and convenience as assessed by Short Form 36 and patient provided feedback.
Time frame: Up to 8 weeks
Determine the overall tolerability, acceptability, and convenience of the intervention using Patient surveys and patient provided feedback.
Number of participants with shorter time to ambulation and weight-bearing as measured by a stopwatch.
Time frame: Up to 8 weeks
CiNPWT effect on ambulation by measuring time to ambulation, time to weight-bearing as measured by a stopwatch.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: Up to 8 weeks
CiNPWT on number of needed physical therapy visits, adverse events, surgical site infection, re-amputation/revision rate, dehiscence, dressing failure, unscheduled/emergency encounters, hospital-acquired pressure injuries.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 23628328Fortington LV, Geertzen JH, van Netten JJ, Postema K, Rommers GM, Dijkstra PU. Short and long term mortality rates after a lower limb amputation. Eur J Vasc Endovasc Surg. 2013 Jul;46(1):124-31. doi: 10.1016/j.ejvs.2013.03.024. Epub 2013 Apr 28.
- Background: PubMed 27890336Low EE, Inkellis E, Morshed S. Complications and revision amputation following trauma-related lower limb loss. Injury. 2017 Feb;48(2):364-370. doi: 10.1016/j.injury.2016.11.019. Epub 2016 Nov 18.
- Background: PubMed 28587576Morisaki K, Yamaoka T, Iwasa K. Risk factors for wound complications and 30-day mortality after major lower limb amputations in patients with peripheral arterial disease. Vascular. 2018 Feb;26(1):12-17. doi: 10.1177/1708538117714197. Epub 2017 Jun 6.
- Background: PubMed 16517350Goldberg T. Postoperative management of lower extremity amputations. Phys Med Rehabil Clin N Am. 2006 Feb;17(1):173-80, vii. doi: 10.1016/j.pmr.2005.10.009.
- Background: PubMed 30774224Ahuja V, Thapa D, Ghai B. Strategies for prevention of lower limb post-amputation pain: A clinical narrative review. J Anaesthesiol Clin Pharmacol. 2018 Oct-Dec;34(4):439-449. doi: 10.4103/joacp.JOACP_126_17.
- Background: PubMed 16180374Nawijn SE, van der Linde H, Emmelot CH, Hofstad CJ. Stump management after trans-tibial amputation: a systematic review. Prosthet Orthot Int. 2005 Apr;29(1):13-26. doi: 10.1080/17461550500066832.
- Background: PubMed 26994715Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.
- Background: PubMed 26424609Scalise A, Calamita R, Tartaglione C, Pierangeli M, Bolletta E, Gioacchini M, Gesuita R, Di Benedetto G. Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature. Int Wound J. 2016 Dec;13(6):1260-1281. doi: 10.1111/iwj.12492. Epub 2015 Oct 1.
- Background: PubMed 28885895Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8.
- Background: PubMed 16291063Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.
- Background: PubMed 22068373Sanders JE, Fatone S. Residual limb volume change: systematic review of measurement and management. J Rehabil Res Dev. 2011;48(8):949-86. doi: 10.1682/jrrd.2010.09.0189.
- Background: PubMed 32789902Zwanenburg PR, Timmermans FW, Timmer AS, Middelkoop E, Tol BT, Lapid O, Obdeijn MC, Gans SL, Boermeester MA. A systematic review evaluating the influence of incisional Negative Pressure Wound Therapy on scarring. Wound Repair Regen. 2021 Jan;29(1):8-19. doi: 10.1111/wrr.12858. Epub 2020 Aug 21.
- Individual participant dataSharing planned: No
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Bone Augmentation, Alveolar Ridge Augmentation
Recruiting
Effect Of Resistive Capactive Electrical Transfer Therapy In Difficult-to-heal Wounds
Difficult-to-heal Wounds
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CINPWT in people with Wound Heal and Wound Dehiscence, run by University of Southern California.
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 0 inclusion and 12 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: withdrawn, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with reduction of edema as assessed using Girth measurements and Grading system. (time frame: Up to 8 weeks). The study lists 4 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 NCT06493539, which also lists 24 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 16 Jan 2026.