NCT04250558 is a clinical trial of Lower Extremity Amputation in Trauma Injury, sponsored by Dartmouth-Hitchcock Medical Center.

Who is sponsoring NCT04250558?

NCT04250558 is sponsored by Dartmouth-Hitchcock Medical Center.

What drugs are being tested in NCT04250558?

Interventions in NCT04250558: Lower Extremity Amputation.

What condition does NCT04250558 study?

NCT04250558 studies Trauma Injury.

Is NCT04250558 still recruiting?

NCT04250558 is currently completed. Last updated 5 June 2025.

Are results published for NCT04250558?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-05 · How we verify

NCT04250558

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ICG Fluorescence Imaging in Lower Extremity Amputation Patients

Completed Results posted Last updated 5 June 2025

What this trial tests

trial testing Lower Extremity Amputation in Trauma Injury in 17 participants. Completed in 30 June 2023.

Timeline

1 February 2020

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	17
Start date	1 February 2020
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

Lower Extremity Amputation

Conditions studied

Trauma Injury — all drugs for Trauma Injury →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Trauma Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Bone Blood Flow (TBBF)-Post Osteotomy Primary · 4 hours

Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.

Group	Value	95% CI
Extremity Amputation	4.9	0 – 30

Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping Primary · 4 hours

Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.

Group	Value	95% CI
Extremity Amputation	0.8	0 – 30

Sponsor's own description

This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Intraoperative fluorescence perfusion assessment should be corrected by a measured subject-specific arterial input function.
Elliott JT, Addante RR, Slobegean GP, Jiang S, et al · · 2020 · cited 21× · PMID 32519522 · DOI 10.1117/1.jbo.25.6.066002
Spatial and temporal patterns in dynamic-contrast enhanced intraoperative fluorescence imaging enable classification of bone perfusion in patients undergoing leg amputation.
Han X, Demidov V, Vaze VS, Jiang S, et al · · 2022 · cited 3× · PMID 35781962 · DOI 10.1364/boe.459497
Fluorescence-guided and molecularly-guided debridement: identifying devitalized and infected tissue in orthopaedic trauma.
Elliott JT, Henderson E, Streeter SS, Demidov V, et al · · 2023 · cited 2× · PMID 37056956 · DOI 10.1117/12.2661243
World Molecular Imaging Congress 2022.
· 2022 · cited 2× · PMID 36648635 · DOI 10.1007/s11307-022-01794-2

Verify or expand the search:

Other recruiting trials for Trauma Injury

Currently open trials in the same condition.

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NCT06606119 — The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma · recruiting
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NCT05721378 — Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures · NA · recruiting

Other Dartmouth-Hitchcock Medical Center trials

Trials by the same sponsor.

NCT07325474 — Plan and Protect: Safety Planning for Teens in Rural Emergency Departments · NA · not yet recruiting
NCT07428629 — Piloting an Insomnia Treatment in Patients With Ulcerative Colitis · NA · not yet recruiting
NCT06777511 — Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients · not yet recruiting
NCT07279116 — ABY-029 Head & Neck Trial · Phase 1 · not yet recruiting
NCT07063693 — ABY-029 Glioma Trial · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04250558 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center
Last refreshed: 5 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04250558.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing