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AzTrials

Achilles Tendon Repairs/ReconstructionsPhase 1SPY NITROPASTENCT07004764

Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.

A Phase 1 study testing Nitroglycerin Ointment 2% in people with Achilles Tendon Repairs/Reconstructions and Pilon Fracture of Tibia, run by Johns Hopkins University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nitroglycerin Ointment 2%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
Nov 2026to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Adults aged 18 years or older.
  • Undergoing surgery for one of the following procedures:
  • Current Procedural Terminology (CPT) 28415 - Open reduction calcaneal fracture ± internal/external fixation
  • CPT-27814 - Open reduction of bimalleolar fracture ± internal/external fixation
  • CPT-27822 - Open reduction trimalleolar ankle fracture, medial and lateral malleoli only, ± internal/external fix
  • CPT-27823 - Open reduction trimalleolar ankle fracture, including posterior malleolus, ± internal/external fix
Show all 15Show fewer
  • CPT-27826 - Open reduction pilon fracture, internal/external fixation of fibula ONLY
  • CPT-27827 - Open reduction pilon fracture, internal/external fixation of tibia ONLY
  • CPT-27828 - Open reduction pilon fracture, internal/external fixation of tibia AND fibula
  • CPT-27535 - Open reduction unicondylar tibial plateau fracture, ± internal/external fixation
  • CPT-27536 - Open reduction bicondylar tibial plateau fracture, ± internal/external fixation
  • CPT-28445 - Open reduction of talus fracture, ± internal/external fixation
  • CPT-27650 - Primary Achilles tendon repair
  • English-speaking
  • Able to provide informed consent during preoperative clinic visit, in the preoperative nursing area, or on inpatient units.

Who cannot join

  • Contraindications to nitroglycerin, including known allergy.
  • Allergy to indocyanine green or components of ICG dye, including allergies to iodine or shell-fish.
  • Severe kidney injury, as determined by attending surgeon and/or anesthesiologist, that would impair clearance of ICG dye.
  • Pregnant patients

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Henry T Shu, MD contact

2408050284

hshu5@jhmi.edu

Babar Shafiq, MD, MSPT contact

4432877847

bshafiq2@jhmi.edu

United States2 sites

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21201

    Henry T Shu, MD, 240-805-0284, hshu5@jhmi.edu

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

    Henry T Shu, MD, 240-805-0284, hshu5@jhmi.edu

Other trials in United States

About this study

Official title: Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.

Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.

Read the detailed description

Tissue perfusion is a critical determinant of wound healing, particularly in lower extremity surgery where wound necrosis, dehiscence, and infection can result in limb loss. Despite current advances in wound therapy, rates of wound complications for certain lower extremity incisions remain high. Thus, there remains a critical need to identify agents that may potentially augment wound healing in orthopaedic surgery.

Nitropaste has been successfully used in plastic surgery to enhance perfusion and reduce flap necrosis, but its role in orthopaedic surgery is under-explored. In a meta-analysis of 6947 patients from 3 randomized controlled trials (RCTs) and 2 retrospective studies found that the use of nitropaste was associated with 0.23 odds [0.10-0.53, 95% confidence interval] of reduced mastectomy flap failure. Preliminary data from the investigator's institution involving 18 patients who received intraoperative nitropaste showed no adverse hypotensive effects, though wound complications occurred in three cases. Laser Assisted Indocyanine Green (LA-ICG) provides real-time, quantitative perfusion measurements, making it an ideal tool to evaluate the efficacy of nitropaste. Therefore, The purpose of this study is to evaluate the effects of nitropaste on immediate tissue perfusion and wound complications in high-risk lower extremity orthopaedic incisions using LA-ICG. Additionally, the investigators will assess the safety of single-dose nitropaste in these patients. The investigators hypothesize that intraoperative nitropaste application will significantly improve tissue perfusion, which in turn would be associated with reduced wound complications, with minimal adverse effects.

Aim 1: To evaluate the effect of nitropaste on immediate tissue perfusion in lower extremity orthopaedic incisions using LA-ICG.

  1. Primary outcomes: Relative fluorescence unit (RFU), absolute fluorescence units (AFU), mean incision perfusion (MIP), and mean perfusion impairment (MPI)
  2. Null hypothesis: The investigators hypothesize that nitropaste would not be associated with a significant increase in perfusion, as measured by RFU, AFU, MIP and MPI.

Aim 2: To assess trial feasibility and ability to identify wound complications for a future large-scale trial.

  1. Primary outcomes: Recruitment rate, retention rate, and wound complications, which include wound dehiscence, wound necrosis, superficial infection, and deep infection.
  2. Recruitment goal: 50% recruitment at 8 months
  3. Retention rate goal: 80% of patients with minimum of 3 months follow-up at trial conclusion
  4. No a priori hypotheses.

Aim 3: To assess the safety of nitropaste in lower extremity orthopaedic surgeries.

  1. Secondary outcomes: Hypotension, headache, dizziness, allergic reactions, and other adverse events.
  2. No a priori hypotheses.
Being tested
Nitroglycerin Ointment 2%
Keywords
Laser-assisted indocyanine green angiography, nitropaste, nitroglycerin, topical nitroglycerin, Achilles tendon repairs/reconstructions, Pilon Fracture of Tibia, Tibial Plateau Fracture, Ankle Fracture (bimalleolar equivalent, bimalleolar, or trimalleolar), Calcaneus Fractures, Talus fracture, Wound Dehiscence, Wound infection, tissue perfusion, Orthopaedic surgery
Medical subject headings
Tibial Plateau Fractures, Ankle Fractures, Surgical Wound Dehiscence, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nitroglycerin Ointment 2%Drug

    Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.

Study groups in NCT07004764
Study groupRoleWhat they receive
NitropasteExperimentalAll patients enrolled in this study will receive a baseline perfusion measurement with the LA-ICG system. This will occur after wound closure. Subsequently, all patients will receive a single dose of nitropaste intraoperatively and a final LA-ICG tissue perfusion measurement.
Receives: Drug: Nitroglycerin Ointment 2%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute fluorescence unit (AFU)

    raw fluorescence measurement

    Measured: Intraoperative measurement

  2. Relative fluorescence unit (RFU)

    Will be calculated as a ratio of the mean fluorescence measure to the mean "normal" measurement. The mean "normal" measurement will be defined as the maximal signal intensity in a region outside of the wound area.

    Measured: Intraoperative measurement

  3. mean incision perfusion (MIP)

    the mean fluorescence of 10 points adjacent to the incision.

    Measured: Intraoperative measurement

  4. mean perfusion impairment (MPI)

    the difference between mean of each pair of points on each side of the incision.

    Measured: Intraoperative measurement

Secondary outcomes (4)

  1. Number of Participants with Wound dehiscence

    participants with wound dehiscence (when two edges of a wound separate)

    Measured: From surgery to 3 months post-operation

  2. Number of participants with Wound necrosis

    participants with any death of peri-incisional skin

    Measured: From surgery to 3 months post-operation

  3. Number of participants with Superficial infection

    participants with any wound infection that is treated only with oral antibiotics

    Measured: From surgery to 3 months post-operation

  4. Number of participants with Deep infection

    Any wound infection that requires surgical management

    Measured: From surgery to 3 months post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2025
  2. Study startNov 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
This study is a single-arm open-label prospective clinical trial with no randomization or placebo. All patients will serve as own controls for LA-ICG fluorescence measurement. This study is considered a Phase I feasibility study, or a Stage 2a Development study under the IDEAL Framework
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07004764
Sponsor's protocol ID
IRB00502503
Acronym
SPY NITROPASTE
Status last verified
Mar 2026
First submitted
27 May 2025
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No sharing will occur to protect patient Protected Health Information (PHI)

Publications

  • Sanniec K, Teotia S, Amirlak B. Management of Tissue Ischemia in Mastectomy Skin Flaps: Algorithm Integrating SPY Angiography and Topical Nitroglycerin. Plast Reconstr Surg Glob Open. 2016 Oct 6;4(10):e1075. doi: 10.1097/GOX.0000000000001075. eCollection 2016 Oct.

    PubMed 27826472

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nitroglycerin Ointment 2% in people with Achilles Tendon Repairs/Reconstructions and Pilon Fracture of Tibia, run by Johns Hopkins University at 2 sites 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 15 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: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Henry T Shu, MD (2408050284, hshu5@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute fluorescence unit (AFU) (time frame: Intraoperative measurement). 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 NCT07004764, which also lists 1 linked publication.

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 31 Mar 2026.

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