---
title: "Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?"
nct_id: NCT01264146
overall_status: COMPLETED
phase: NA
sponsor: RWTH Aachen University
study_type: INTERVENTIONAL
primary_condition: Microcirculation
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01264146.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01264146"
ct_last_update_post_date: 2012-11-27
last_seen_at: "2026-05-12T07:01:12.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hyperbaric Oxygen Therapy in Calcaneal Intraarticular Fractures: Can it Decrease the Soft-tissue Complication Rate?

**NCT ID:** [NCT01264146](https://clinicaltrials.gov/study/NCT01264146)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** RWTH Aachen University
- **Conditions:** Microcirculation, Wound Healing
- **Start Date:** 2011-04
- **Completion Date:** 2012-11
- **CT.gov Last Update:** 2012-11-27

## Brief Summary

This study aims to test the hypothesis that postoperative daily hyperbaric oxygen therapy (HBOT) decreases soft-tissue complication rate during the operative handling of intra-articular calcaneal fractures. Minor motivations: 1. To evaluate microcirculatory criteria of cutaneous tissue predicting emerging wound healing defects, 2. To identify patients at risk for soft-tissue complication after calcaneal plate osteosynthesis and to determine the optimal time point for operative intervention using these microcirculatory criteria preoperatively, 3. To evaluate the effect of HBOT on postoperative microcirculation, 4. To collect preliminary data to evaluate the economical impact of wound complications, with and without HBOT, 5. To identify a correlation between HBOT with expected limited soft-tissue complication rate and the clinical and radiographic outcome two years after surgery.

## Detailed Description

Wound complication remains an important problem in calcaneal fractures, with some plate series quoting up to a 27% infection rate. The original hypothesis stimulating this study is that HBOT after calcaneal plating can decrease such high rates of infection. Validation of this hypothesis would not only alter guidelines for standard procedure (plate osteosynthesis), but would also help to avoid difficult follow-up operations and improve functional outcome after calcaneal fracture. To date, this therapeutic approach has not been systematically tested in the existing literature. As further motivation for this study, the assessment of the existent microcirculation as a potential screening parameter will be analysed. In order to do so, it is assumed that wound infection partially develops due to disruptions in the microcirculation. This leads to the hypotheses, that by measuring the microcirculation, patients at high risk for post operative infections could be identified before operation, planning a different less invasive approach or conservative treatment.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Acute displaced intraarticular calcaneal fracture

Exclusion Criteria:

* Extraarticular or open fracture, re-fracture or past surgical procedures in calcaneal region, peripheral vascular disease, insulin dependent diabetes mellitus, macroangiopathy: Study population is representative for all calcaneal fractures
```

## Arms

- **calcaneal plating HBOT** (ACTIVE_COMPARATOR) — Open reduction and internal fixation of calcaneal fracture + HBOT
- **calcaneal plating** (PLACEBO_COMPARATOR) — Open reduction and internal fixation of calcaneal fracture + Placebo (Sham)

## Interventions

- **HBOT** (PROCEDURE) — Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)
- **Placebo (Sham)** (PROCEDURE) — open reduction and internal fixation of calcaneal fracture + Placebo (Sham)

## Primary Outcomes

- **Postoperative rate of wound complication after calcaneal plating** _(time frame: 30 days)_ — Rate of postoperative wound edge necrosis and superficial or deep infection determined by wound redness, secretion of pus, detection of a microbial agens, CRP elevation and detection of fluid by sonography.

## Secondary Outcomes

- **Effect of HBOT on postoperative microcirculation of the foot, clinical outcome** _(time frame: 2 years)_

## Locations (1)

- RWTH Aachen University, Aachen, Germany

## Recent Field Changes (last 30 days)

- `locations.rwth aachen university|aachen||germany` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01264146*  
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