Clinical Trials Directory

Trials / Completed

CompletedNCT02855983

Perforating Fat Injections for Plantar Fasciosis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

The specific aim of this study is to determine whether perforating fat injections to the plantar fascia is a safe method to improve pain, quality of life, and reduce plantar fascia thickness for patients with chronic plantar fasciitis. We will also correlate the intrinsic fat properties of adipose stem cells (ie. growth factors) to the improvement in pain, quality of life, and plantar fascia thickness over time.

Detailed description

Aim 1: Evaluate the safety of perforating fat injection into the plantar fascia in patients with chronic plantar fasciitis to improve pain, quality of life, and thickness of the fascia. Rationale: Perforating fat injections have been shown to improve multiple scar and fibrotic conditions such as burn scar contracture, breast radiation injury, and Dupuytren's contracture of the hand. (5-7) It is thought that the perforations allow expansion of the tissues, and filling them with fat allows for a regenerative healing process, rather than an inflammatory scar healing process. Hypothesis: Perforating fat injections into the chronically thickened plantar fascia is a safe method to improve pain, quality of life, and reduce tissue thickness. Aim 2: Correlate intrinsic fat properties of lipoaspirate to improvement in function and plantar fascia thickness. Rationale: Adipose tissue contains adipose derived stem cells. Various growth factors released from the stem cells may have a local effect on soft tissues (ie. VEGF). (8) These stem cells are thought to promote regenerative healing, rather than scar formation and may ultimately improve the thickness of the plantar fascia. (9-12) Hypothesis: Intrinsic fat properties of lipoaspirate (adipose stem cell characteristics) are closely correlated to the improvements in quality of life and thickness of the plantar fascia.

Conditions

Interventions

TypeNameDescription
PROCEDUREFat GraftingGrafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 2mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the graft site. This surgical procedure involves the immediate transplantation of a patient's own tissue in a single operative procedure.

Timeline

Start date
2016-08-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2016-08-04
Last updated
2020-01-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02855983. Inclusion in this directory is not an endorsement.