Autopsy report · NCT04078854

The Impact of Sexual Health and Amputation Focused Education on Regulation of Glucose and Amputation Prevention

“IRB approval expired on 3/16/2022. Study would need to be reapproved by the IRB with a new submission given the duration of expiration.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months before it started.
• Ran for about 1 year 8 months before it stopped.
• 21 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Montefiore Medical Center

Sponsor type

University, hospital or other

Conditions

Diabetic Ulcers on Both Feet; Amputation; Traumatic, Limb; Sexual Dysfunction; Diabetic Foot Ulcer Ischemic

Interventions

Diabetes education

Participants

21

Sites

1

Countries

United States

Trials that died the same way

• Change In Diaphragmatic Thickness Predicts Extubation Success
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• Virtual Reality Education Module in Reducing Anxiety and Increasing Knowledge in Patients With Prostate Cancer Undergoing Radiation Therapy
  “The study expired at the IRB” (83% match in meaning)
• Adherence to Otezla
  “Terminated IRB approval 6/26/2024, study was never initiated or activated” (82% match in meaning)
• Postop Pain Control in Hip Fracture Surgery: Fascia Iliaca Compartment Block Versus Fracture Block
  “Study was withdrawn. Study expired in IRB system and no patients enrolled as per institutional CTMS and IRB systems. Primary and Study Completion Dates reflect date IRB approval expired.” (81% match in meaning)
• Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia
  “Study halted prematurely; IRB approval not obtained” (80% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.